Devices and methods for forming a fistula

ABSTRACT

Described here are devices, systems, and methods for forming a fistula between two blood vessels. The systems may comprise a first catheter including a housing and an electrode having a proximal end and a distal end. The proximal end is fixed relative to the housing and the distal end is longitudinally slidable within the housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/399,471, filed Sep. 25, 2016, and titled “DEVICES AND METHODS FORFORMING A FISTULA” and U.S. Provisional Application No. 62/279,603,filed Jan. 15, 2016, and titled “DEVICES AND METHODS FOR FORMING AFISTULA,” each of which is hereby incorporated by reference in itsentirety.

FIELD

The current invention relates to devices and methods for forming afistula. The devices and methods may be used to form a fistula betweentwo blood vessels.

BACKGROUND

A fistula is generally a passageway formed between two internal organs.Forming a fistula between two blood vessels can have one or morebeneficial functions. For example, the formation of a fistula between anartery and a vein may provide access to the vasculature for hemodialysispatients. Specifically, forming a fistula between an artery and a veinallows blood to flow quickly between the vessels while bypassing thecapillaries. In other instances, a fistula may be formed between twoveins to form a veno-venous fistula. Generally, fistula formationrequires surgical dissection of a target vein, and transecting andmoving the vein for surgical anastomosis to the artery. It may thereforebe useful to find improved ways to form a fistula between two bloodvessels.

BRIEF SUMMARY

Described here are devices, systems, and methods for forming a fistulabetween two or more blood vessels. Generally, the system for forming afistula between two vessels described here comprises a first catheterincluding a housing and an electrode having a proximal end and a distalend. The proximal end may be fixed relative to the housing and thedistal end may be longitudinally slidable within the housing.

In some variations, the housing may comprise an opening and theelectrode may comprise an intermediate portion between the proximal endand the distal end. In some variations, the intermediate portion mayextend into and out of the opening. In some variations, the electrodemay comprise a leaf spring. In some variations, the first catheter maycomprise a fluid seal to prevent fluid ingress into the first catheterat the proximal end of the electrode. In some variations, the housingmay comprise a heat insulating portion adjacent to at least the proximalend of the electrode. In some variations, the electrode may vary inwidth and/or height along its length. In some variations, the electrodemay be configured to self-expand away from the housing. For example, auser may not need to actuate the electrode between a low-profileconfiguration and an extended configuration.

In some of these variations, the intermediate portion of the electrodemay comprise a plurality of bends. In other of these variations, theintermediate portion may comprise a bend of less than about 40 degrees.In some variations, the electrode may comprise a low-profileconfiguration in which the electrode is recessed into the housing. Insome variations, the housing may comprise a reservoir between theproximal end of the electrode and a distal end of the first catheter.The reservoir may be configured to hold fluid. The electrode may beconfigured to generate plasma from the fluid in the reservoir. In somevariations, a feedback circuit may be configured to apply a constantsquare wave voltage to the electrode.

In some variations, a second catheter may comprise a second housing anda protruding backstop. In some of these variations, the protrudingbackstop comprises a compression region configured to oppose theelectrode and compress tissue therebetween. In some of these variations,the electrode is configured to ablate the tissue along a length based ona length of the compression region. In some of these variations, thesecond catheter may comprise a recessed portion opposite the protrudingbackstop. The recessed portion may have a complementary shape to theprotruding backstop. In some of these variations, the system maycomprise an introducer sheath. The protruding backstop and the recessedportion may be within the introducer sheath.

In some variations, the system may further comprise a second cathetercomprising a recessed backstop. The recessed backstop may have a shapethat is complementary to a portion of the electrode. In some of thesevariations, the electrode may comprise an intermediate portion betweenthe proximal end and the distal end. The recessed backstop may have ashape that is complementary to the intermediate portion of theelectrode. In some of these variations, the electrode may comprise anextended configuration in which the electrode is extended away from thehousing. The complementary shape may correspond to a shape of theelectrode in the extended configuration. In some of these variations,the shape may comprise a concave portion comprising an openingconfigured to receive the electrode. In some of these variations, theelectrode may be configured to bias towards the extended configuration.

In some variations, the first catheter may comprise a first coaptionregion comprising a flat coaption surface. In some of these variations,the first coaption region may have a square or rectangularcross-section. In other of these variations, the system may furthercomprise a second catheter comprising a second coaption regioncomprising a flat coaption surface. In some of these variations, thesecond coaption region may have a square or rectangular cross-section.In some of these variations, the first coaption region may comprise afirst magnet and the second coaption region may comprise a secondmagnet.

The system may include one or more additional features. In somevariations, the first catheter may comprise a first handle, and thesystem may further comprise a second catheter comprising a secondhandle. The first handle and the second handle may each comprise a flatsurface. In some of these variations, the first catheter may comprise afirst shaft and the second catheter may comprise a second shaft. Thefirst shaft and the second shaft may each comprise braiding configuredto enhance torsional stiffness. In some of these variations, the firsthandle may comprise a first magnet and the second handle may comprise asecond magnet.

In some variations, the first catheter comprises a rotational indicatorcomprising a radiopaque material. In some of these variations, therotational indicator may comprise a radiopaque film. In some of thesevariations, the radiopaque film may have a thickness of about 0.025 mm.In other of these variations, the rotational indicator may have a squareor rectangular cross-section. In other of these variations, therotational indicator may have a cross-section having a shape of awritten character. In other of these variations, the rotationalindicator may comprise a cube comprising a cylindrical cut-out. In otherof these variations, the rotational indicator may comprise anarrow-shaped cut-out.

Also described herein are other systems for forming a fistula betweentwo blood vessels. In general, these devices described herein maycomprise a first catheter having a fixed height electrode comprising awire comprising an internal portion and an external portion, and aprotrusion. In some variations, the fixed height electrode may beconfigured to be supported by the protrusion. In some variations, theexternal portion of the fixed height electrode may extend away from thehousing by up to about 3 mm.

Also described here are methods of forming a fistula between two bloodvessels. In one variation, a method of forming a fistula between twovessels comprises advancing a first catheter into a first blood vessel.The first catheter may comprise an electrode. The method may furthercomprise ablating tissue with the electrode. Ablating tissue maycomprise applying a constant square wave voltage to the electrode.

In some of these variations, the catheter may comprise a housing and theelectrode may comprise a proximal end and a distal end. The proximal endmay be fixed relative to the housing and the distal end may belongitudinally slidable within the housing. In other of thesevariations, a second catheter comprising a backstop may be advanced intoa second blood vessel.

In some of these variations, the first catheter may comprise a firstcoaption region comprising a first magnet and the second catheter maycomprise a second coaption region comprising a second magnet. Magneticattraction forces between the first magnet and the second magnet maycompress tissue between the backstop and the electrode.

Other methods of forming a fistula between two vessels are alsodescribed herein and may comprise advancing a first catheter into afirst blood vessel and a second catheter into a second blood vessel. Thefirst catheter may comprise a first electrode and the second cathetermay comprise a conductive portion. Tissue in the first blood vessel andthe second blood vessel may be ablated with the first electrode. Thefirst electrode may contact the conductive portion after the tissue isablated. Tissue in the second blood vessel may be ablated with theconductive portion while the conductive portion is in contact with thefirst electrode. In some variations, the first blood vessel may comprisea venous blood vessel and the second blood vessel may comprise anarterial blood vessel.

In some variations, a method of forming a fistula between two vesselsmay comprise advancing a first catheter into a first blood vessel and asecond catheter into a second blood vessel. The first catheter maycomprise a first electrode and the second catheter may comprise a secondelectrode. An ablation cycle may be performed and comprise measuring afirst impedance between the first electrode and the second electrode,selecting an ablation parameter based on the first impedance, ablatingtissue based on the selected ablation parameter, measuring a secondimpedance between the first electrode and the second electrode, anddetermining that a fistula has been created based on the secondimpedance.

In some variations, determining that the fistula has been created maycomprise measuring a second impedance of about 150 ohms or less betweenthe first electrode and the second electrode. In some of thesevariations, measuring may comprise measuring the first impedance and thesecond impedance over a measurement period of about 20 msec and ablatingtissue comprises ablating tissue for an ablation period of about 40msec. In some of these variations, the measuring may comprise measuringthe first impedance and the second impedance over a measurement periodof about 1 second and ablating tissue comprises ablating tissue for anablation period of about 500 msec. In some of these variations, a firstcurrent and a second current may be applied to the electrode to induceneuromuscular stimulation, and a distance of a nerve to a fistula sitemay be calculated based on the induced neuromuscular stimulation. Insome of these variations, the first current may comprise about 1microampere and the second current may comprise about 3 microamperes. Inother of these variations, the first catheter and the second cathetermay be repositioned based on the distance of the nerve to the fistulasite. In some variations, a denaturing parameter may be selected basedon the first impedance, and tissue may be denatured based on theselected denaturing parameters to shrink the tissue.

Also described here are methods of positioning a first catheter and asecond catheter within two vessels may comprise advancing a firstcatheter into a first blood vessel and a second catheter into a secondblood vessel. The first catheter may comprise a first radiopaque portionand the second catheter may comprise a second radiopaque portion. Anorientation of the first radiopaque portion and the second radiopaqueportion may be fluoroscopically imaged using an X-ray beam. Theorientation of the first radiopaque portion may be matched to that ofthe second radiopaque portion. The X-ray beam may be non-perpendicularto the first and second radiopaque portions.

Also described here are methods of positioning a first catheter within afirst blood vessel and a second catheter within a second blood vesselcomprising advancing the first catheter into the first blood vessel andthe second catheter into the second blood vessel. The first catheter maycomprise a first electrode and the second catheter may comprise a secondelectrode. An impedance may be measured between the first electrode andthe second electrode. The first catheter may be aligned with the secondcatheter based on the measured impedance.

In some variations, aligning the first catheter with the second cathetermay comprise rotationally and axially aligning the first catheter to thesecond catheter. In some variations, an audio and/or visual alignmentsignal may be generated based on the measured impedance.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a portion of a catheter comprising anelectrode. FIG. 1B is a cross-sectional perspective view of a portion ofthe catheter of FIG. 1A.

FIGS. 2A-2B are cross-sectional side views of a portion of the catheterof FIG. 1A, showing the electrode in extended (FIG. 2A) and low-profile(FIG. 2B) configurations.

FIGS. 3A-3C are cross-sectional side views (FIG. 3A) and cross-sectionalperspective views (FIGS. 3B-3C) of portions of the housing and electrodeof the catheter of FIG. 1A.

FIG. 4 is a cross-sectional side view of a portion of the housing andelectrode of the catheter of FIG. 1A.

FIG. 5 is a perspective view of a portion of another variation of acatheter housing and electrode.

FIGS. 6A-6B are cross-sectional side views of portions of othervariations of catheters comprising bent electrodes. FIG. 6C is aperspective view of a portion of another variation of a cathetercomprising a bent electrode.

FIGS. 7A-7B are depictions of a portion of another variation of thecatheter comprising a fixed electrode. FIG. 7A is a perspective view andFIG. 7B is a cross-sectional side view.

FIG. 8 is a plan view of another variation of an electrode.

FIGS. 9A-9P are illustrative depictions of variations of electrodeshapes.

FIGS. 10A-10B are plan views of an electrode having variations of anelectrode shape.

FIGS. 11A-11B are illustrative depictions of a fistula formed by anelectrode having a shape as in FIG. 9L. FIG. 11A is a side view and FIG.11B is a cross-sectional view of two vessels having a fistula formedtherebetween.

FIGS. 12A-12B illustrate side views of fistulas with strain relief ends.

FIGS. 13A-13B depict portions of another variation of a systemcomprising a first catheter having an electrode and a second catheterhaving a backstop. FIG. 13A is a perspective view of a portion of thesecond catheter. FIG. 13B is a cross-sectional side view of portions ofthe first catheter and the second catheter.

FIGS. 14A-14C depict portions of another variation of a systemcomprising a first catheter having an electrode and a second catheterhaving a backstop. FIG. 14A is a perspective view of a portion of thesecond catheter. FIG. 14B is a side view of a portion of the secondcatheter. FIG. 14C is a cross-sectional side view of portions of thefirst catheter and the second catheter.

FIGS. 15A-15B depict perspective and cross-sectional side views,respectively, of a portion of another variation of a system comprising afirst catheter having an electrode and a second catheter having abackstop.

FIG. 16 is a cross-sectional side view of a portion of another variationof a system comprising a first catheter having an electrode and a secondcatheter having a backstop.

FIGS. 17A-17C depict portions of another variation of a systemcomprising a first catheter having an electrode and a second catheterhaving a backstop. FIG. 17A is a perspective view of a portion of thesecond catheter. FIG. 17B is a cross-sectional perspective view of aportion of the second catheter. FIG. 17C is a cross-sectional side viewof a portion of the first catheter and the second catheter.

FIGS. 18A-18B are cross-sectional side views of portions of variationsof systems comprising a first catheter having an electrode and a secondcatheter having a backstop.

FIGS. 19A-19D depict another variation of a system comprising first andsecond catheters comprising respective first and second electrodes. FIG.19A is a perspective view of a portion of the first catheter and thesecond catheter. FIG. 19B is a side view of a portion of the firstcatheter and the second catheter. FIGS. 19C-19D are cross-sectional sideviews of portions of the first catheter and the second catheter.

FIGS. 20A-20D depict several variations of a system comprising a firstcatheter comprising an electrode and a second catheter comprising aconductive portion. FIG. 20A is a perspective view of a portion of thesecond catheter comprising the conductive portion. FIGS. 20B-20D arecross-sectional side views of portions of the first and second cathetersin blood vessels.

FIGS. 21A-21E are side views of several variations of a cathetercomprising a conductive portion.

FIGS. 22A-22D depict another variation of a system comprising a firstcatheter and second catheter having respective first and secondelectrodes. FIGS. 22A-22B are plan views, and FIGS. 22C-22D arecross-sectional views.

FIGS. 23A-23D depict another variation of a system including a firstcatheter comprising an electrode and a second catheter comprising abackstop. FIGS. 23A and 23B are perspective views of portions of thefirst catheter and second catheter. FIGS. 23C-23D are cross-sectionalside views of portions of the first catheter and the second catheter.

FIGS. 24A-24B are illustrative depictions of a variation of a rotationalindicator. FIG. 24C depicts visualized rotational indicator width as afunction of rotational error of the rotational indicator of FIGS.24A-24B.

FIGS. 25A-25B are illustrative depictions of another variation of arotational indicator. FIG. 25A is a perspective view and FIG. 25B is aside view of the rotational indicator. FIG. 25C depicts fluoroscopicvisualization of rotational indicators similar to those depicted inFIGS. 25A-25B having varying thicknesses and orientation.

FIGS. 26A-26C are illustrative depictions of another variation of arotational indicator. FIGS. 26A and 26C are perspective views and FIG.25B is a side view of the rotational indicator. FIG. 26D depictsfluoroscopic visualization of rotational indicators similar to thosedepicted in FIGS. 26A-26C having varying hole diameters and orientation.

FIG. 27 is a cross-sectional side view of a distal portion of anothervariation of a system comprising first and second catheters eachcomprising a coaption region.

FIGS. 28A-28C depict fluoroscopic visualizations of another variation ofa rotational indicator having different orientations.

FIGS. 29A-29B are side and perspective views, respectively, of anothervariation of a rotational indicator.

FIG. 30 is a cross-sectional side view of another variation of arotational indicator.

FIG. 31 is a perspective view of another variation of a rotationalindicator.

FIGS. 32A-32B are fluoroscopic visualizations of another variation of asystem comprising first and second catheters each comprising rotationalindicators.

FIG. 33 is a perspective view of a variation of handles of first andsecond catheters.

FIGS. 34A-34C depict another variation of a handle portion of acatheter. FIG. 34A is a perspective view of the handle. FIG. 34B is aperspective view of the handle with a top portion removed. FIG. 34C is across-sectional perspective view of the handle.

FIG. 35 is a flowchart illustrating a variation of a method for forminga fistula.

FIGS. 36A-36G are various side and perspective views of portions ofanother variation of a catheter system. FIG. 36A shows a side view of adistal portion of the catheters, FIG. 36B shows a cross-sectional sideview of the catheter depicted in FIG. 36A, FIG. 36C shows an electricalplug of the catheter, FIG. 36D shows a side view of the electrode andbackstop depicted in FIG. 36A, FIG. 36E shows a perspective view of thecatheter system, FIG. 36F shows an introducer sheath over the catheter,and FIG. 36G shows a handle of the catheter.

DETAILED DESCRIPTION

Generally described here are devices, systems, and methods for forming afistula. In some variations, the devices and methods may be used to forma fistula between two blood vessels (e.g., an arteriovenous fistulabetween an artery and a vein or a veno-venous fistula between twoveins). Generally, to form such a fistula between two blood vessels, oneor more catheters may be advanced in a minimally invasive fashionthrough the vasculature to a target location. In some instances, asingle catheter may be placed in a blood vessel to form a fistula withan adjoining blood vessel. In other instances, a system comprisingmultiple catheters may be used to form a fistula. For example, in someinstances a catheter may be placed in each of the two blood vessels. Inthese instances, it should be appreciated that each catheter may or maynot have the same configuration of elements, and that some catheters maybe different from and/or complementary to other catheters, as will bedescribed in more detail below. In some variations, the catheter may beremoved from the vasculature after fistula formation without leavingforeign objects in the body such as a stent, coil, plug, and so forth.In some instances, a catheter configuration may be selected based on thefistula to be formed and the vessels in which the fistula is to belocated. The variations as described herein below may improve treatmentoutcomes and reduce complications associated with fistula formation.

Generally, the systems described here comprise one or more catheters.The at least one catheter may generally comprise a housing and afistula-forming element such as an electrode. The electrode may beattached to the housing and used to ablate tissue to form a fistula.During ablation, sufficient energy may be delivered to tissue such thatthe tissue is removed to form a fistula. A size and shape of anelectrode and the energy applied to the electrode may be selected toform a desired fistula with minimal energy to reduce collateral damageto tissue. The electrodes described herein may allow targeted fistulaformation that may accommodate a wide range of patients and fistularequirements. In some instances, an electrode may be configured to beadvanced through blood vessels of varying diameters without damagingtissue. Once positioned at a fistula formation site, the electrode mayin some variations naturally extend into proper position without usermanipulation. During fistula formation, the electrode may continue toextend as tissue is ablated. As such, a separate electrode actuationmechanism may be rendered moot. The electrode may be formed compactly toreduce a size of the catheter and/or manufacturing complexity.

In some variations of the system, a first catheter and a second cathetermay be complementary to each other where, for example, the firstcatheter may comprise an electrode and the second catheter may comprisea backstop that may shape and control tissue ablation performed by thefirst catheter electrode. In other variations, a first catheter and asecond catheter may each comprise at least one electrode. In some ofthese variations, the first and second catheter may each comprise atleast one electrode, and the electrode(s) of one of the catheters may bean active electrode, while the electrode(s) of the other of thecatheters may be a return electrode. In others of these variations, thefirst and second catheters may form a dual ablation system that may beenergized to ablate tissue from opposing sides. This may in someinstances reduce an ablation time. The electrodes may be activated in asimultaneous ablation mode, alternating mode, or a combination of modes.The dual ablation systems described in more detail herein may improvesafety, decrease a fistula formation time, and/or allow for a compactcatheter system. In other variations, synergistic ablation may beprovided where a conductive portion of one catheter is activated byelectrode activation of another catheter. For example, an activatedfirst electrode may contact a second catheter to energize a conductiveportion of the second electrode.

The catheter may further comprise one or more alignment features thathelp align one catheter relative to another catheter in adjacent bloodvessels and/or bring the catheters (and blood vessels) in closerapproximation relative to each other. Alignment of the cathetersrelative to each other may position the fistula-forming element(s)(e.g., electrodes) of the catheters at a desired axial location and/orrotational angle relative to each other when both catheters comprise atleast one fistula-forming element. When only one of two catheterscomprise a fistula-forming element, alignment of the catheters relativeto each other may position the fistula-forming element(s) of a firstcatheter at a desired axial and/or rotational angle relative to acorresponding component of a second catheter (e.g., a backstop). In someinstances, alignment features of two catheters may hold respective bloodvessels in a desired position throughout fistula formation and may helpachieve efficient fistula formation with reduced collateral damage. Inthese or other instances, the alignment features may stretch and/orcompress tissue at a fistula site in such a manner to allow tissue to beablated more quickly and with less energy.

Furthermore, the alignment features as discussed in detail herein mayincrease user confidence in achieving catheter alignment and do so witha reduced amount of effort. In some variations, the alignment featuresmay comprise one or more magnets, coaption surfaces (e.g., flatsurfaces), visual alignment aids, and/or handles. For instance, opposingmagnetic coaption surfaces may bring the catheters into rotationalalignment with each other and closer together with the blood vessels. Insome variations, at least a portion of the catheters described hereinmay have a square cross-sectional shape in order to promote rotationalalignment. Magnets located within these catheters may also have a squarecross-sectional shape. In some variations, the catheters may comprisemagnet arrays comprising a plurality of square magnets. Additionally oralternatively, a handle may be used to align at least a portion of onecatheter relative to at least a portion of another catheter. In somevariations, a rotational indicator may be visualized under fluoroscopyfor a user to visualize the catheters in the blood vessels andmanipulate the catheter(s) into a desired position.

The electrodes disclosed herein may in some variations not only ablatetissue, but may also measure tissue and/or fistula characteristics(e.g., impedance) such as for catheter alignment and confirming fistulaformation. The electrodes may be connected to, for example, a generatorunder control of an electrosurgical controller. Energy delivery may betuned by the controller to improve fistula formation and limitcollateral damage to tissue based on, for example, measured impedancedata.

One or a combination of the catheters described herein may be used toform a fistula, as will be described in more detail herein. Generally,the methods described herein for forming a fistula between two vesselsmay comprise advancing a first catheter into a blood vessel in aminimally invasive manner through vasculature. After aligning thecatheters at a desired location, the vessels may optionally be measuredto determine tissue characteristics for tissue modification based on themeasurement. Power may then be delivered to one or more electrodes toablate tissue. For instance, an electrosurgical controller may controlenergy delivery based on real-time measurements to improve energyefficiency and reduce ablation time. In other variations, the amount ofenergy delivered may be fixed or predetermined. The catheters may beremoved upon confirmation of fistula formation, which may optionally beconfirmed via measurement of one or more properties. As disclosed inmore detail herein, the methods described here may improve fistulapatency and longevity using less energy, time, and damage to tissue.

I. Systems

A. Catheters

Generally, the systems and devices described here may be useful inmeasuring, modifying, and ablating tissue to form a fistula. The systemsdescribed here typically comprise one or more catheters. The one or morecatheters may comprise one or more fistula-forming elements. Thecatheters may be configured to be advanced through vasculature in aminimally invasive manner. In some variations, a fistula may be formedby one or more active electrodes of one catheter. In other variations,two catheters each comprising one or more electrodes may simultaneouslyablate tissue from opposing sides to form a fistula. In some othervariations, a first catheter comprising one or more electrodes may forma fistula with a second catheter comprising one or more backstopsopposing the one or more electrodes. In still other variations, a firstcatheter comprising one or more electrodes may form a fistula with asecond catheter comprising one or more conductive portions, where theone or more conductive portions form a return electrode or are energizedby contact with one or more electrodes of the first catheter.

The catheters may have any suitable diameter for intravascular use, suchas, for example, about 4 French, about 5.7 French, about 6.1 French,about 7 French, about 8.3 French, between about 4 French and about 9French, between about 4 French and about 7 French, between about 4French and about 6 French, or the like. The catheters described mayfurther comprise elements to aid in visualization and/or alignment ofone or more catheters as described in more detail herein. Any suitablecatheter or catheters may be used with the systems described herein toform the fistulas using the methods described herein.

FIG. 1A is a perspective view of a distal portion of an illustrativefirst catheter (100) that may be used to form a fistula between twovessels. The first catheter (100) may comprise a housing (102). Anelectrode (106) may protrude from an opening (104) of the housing (102),and may be activated to form a fistula. In some variations, the housing(102) may comprise one or more insulating materials which may shield orotherwise protect the catheter (100) and its components from heatgenerated by the electrode (106) during use. For instance, one or moreportions of the housing (102) adjacent to the electrode (106) maycomprise a heat insulating portion that may be ceramic.

The catheters may additionally comprise one or more lumens orpassageways extending at least partially along or through the catheter.The distal end of the catheter may be configured to aid in advancementof the catheter and/or to be atraumatic. In some variations, the distalend may comprise one or more rapid exchange portions or other lumens foradvancement of the catheter over a guidewire. In still other variations,the distal end may have a guidewire attached to or otherwise integrallyformed with the catheter.

B. Fistula-Forming Elements

As mentioned above, the catheters described here may comprise one ormore elements for forming a fistula. A fistula-forming element maycomprise any element capable of forming a fistula between two vessels.For example, the fistula-forming element may comprise one or moreelectrical mechanisms (e.g., electrodes or electrocautery mechanisms).Generally, at least a portion of each electrode may be exposed to thesurrounding environment (e.g., through one or more openings in acatheter housing) when the catheter is in a configuration for fistulaformation. This exposed electrode surface may be configured to contactsurrounding tissue (e.g., a blood vessel wall) and/or fluids, and mayact as an ablation surface such that current may be supplied to and/orcarried from tissue and fluid via the ablation surface to facilitateablation (e.g., dissolution of solids) or vaporization (e.g., fluid togas phase change) of tissue. In some variations, the exposed electrodesurfaces may additionally or alternatively be used to perform differentfunctions other than fistula formation. For example, the exposedelectrode surface may be used to deliver an amount of energy that causesit to act as a heating surface to heat and modify tissue, rather thanremoving tissue to form a fistula. Additionally or alternatively, insome variations the electrode may be used to apply neuromuscularstimulation. Additionally or alternatively, in some variations theelectrode may be used to measure tissue and/or fistula characteristics.

1. Low-Profile and Extended Configurations

In some variations, the electrodes described herein may be configured tohave a low-profile configuration and an extended configuration. In thelow-profile configuration, the electrode may be configured to beatraumatic when the catheter comprising the electrode is delivered to alocation for fistula formation. For example, in the low-profileconfiguration, the electrode may be recessed into the catheter body,such that the outer surface of the electrode does not extend radiallybeyond the outer surface of the catheter body. As such, the cathetercomprising the electrode may be delivered through a tubular body (e.g.,blood vessel, sheath) in an atraumatic fashion. In some variations, theouter surface of the electrode may be flush with the outer surface ofthe catheter body in the low-profile configuration, while in othervariations the outer surface of the electrode may be below the outersurface of the catheter body in the low-profile configuration. In theextended configuration, at least a portion of the electrode may extendradially outward from the outer surface of the catheter body (i.e.,radially beyond the outer surface of the catheter body), and a portionof the electrode may be spaced away from the outer surface of thecatheter body. As such, the electrode may contact, and in some instancespress into, tissue in order to form a fistula (as described in moredetail herein).

In some variations, the electrodes described herein may be biased towardthe extended configuration. That is, the electrode may be configured toself-expand from the low-profile configuration to the extendedconfiguration. In some variations, the electrode may be held in thelow-profile configuration by the inner surface of a vessel wall duringdelivery. The electrode may then self-expand toward the extendedconfiguration as energy delivery through the electrode results in tissueablation (as described in more detail herein). In other variations, theelectrode may be held in the low-profile configuration by anothercomponent of the catheter system, such as but not limited to a sheath.

The electrode may have any suitable shape in the low-profile andextended configurations. For example, in some variations the electrodemay be curved, such that in an extended configuration it forms a convexcurve extending away from the outer surface of the catheter body. Whenthe electrode moves from a low-profile to an extended configuration, theradius of curvature of the electrode may decrease, causing the electrodeto protrude from the catheter body. Conversely, when the electrode movesfrom an extended configuration to a low-profile configuration, theradius of curvature of the electrode may increase, causing the electrodeto recess into the catheter body. As another example, in some variationsthe electrode may comprise one or more bends that allow it to movebetween low-profile and extended configurations.

In some variations, the electrodes described herein may be configuredsuch that one or both ends of the electrode slide within the catheterbody when the electrode moves between low-profile and extendedconfigurations. For example, an electrode may comprise a first end and asecond end, where both the first and second ends are located within thecatheter body. A first end of the electrode may be fixed, while a secondend of the electrode may be slidable within a lumen inside of thecatheter body. When the slidable second end of the electrode movestoward the fixed first end of the electrode, the electrode may movetoward an extended configuration. When the slidable second end of theelectrode moves away from the fixed first end of the electrode, theelectrode may move toward a low-profile configuration. If the electrodeis curved, for example, as the slidable second end moves toward thefixed first end of the electrode, the radius of curvature of theelectrode may decrease, causing the electrode to protrude from thecatheter body.

An example of such a curved electrode is shown in FIGS. 1A-2B. Shown inFIG. 1A is a distal portion of an exemplary catheter (100) comprising anelectrode (106), with the electrode (106) shown in an extendedconfiguration. FIG. 1B is a cross-sectional perspective view of thecatheter (100). The housing (102) of the catheter comprises an opening(104), through which the electrode (106) may extend when in the extendedconfiguration. As shown in FIG. 1B, the electrode (106) may comprise aproximal end (108), a distal end (112), and an intermediate portion(110) between the proximal end (108) and distal end (112). The electrode(106) may comprise a proximal bend (114) between the proximal end (108)and the intermediate portion (110), an intermediate bend (116) withinthe intermediate portion (110), and a distal bend (118) within thedistal end (112). The proximal end (108) of the electrode (106) may befixed relative to the housing (102) in order to fix an axial and/orrotational orientation of the distal end (112) of the electrode (106)relative to the housing (102). The distal end (112) of the electrode(106) may be located within a lumen (120) within the catheter housing(102). The distal end (112) of the electrode (106) may be able to slidedistally and proximally within the lumen (120) (e.g., slidelongitudinally within the housing (102)), such that the intermediateportion (110) of the electrode (106) extends into and out of the opening(104) in the housing (102).

FIGS. 2A-2B illustrate detailed cross-sectional side views of theelectrode (106) in various states of extension and recession withrespect to a catheter housing (102). FIG. 2A illustrates the electrode(106) in an extended configuration. In the extended configuration, theintermediate portion (110) of the electrode (106) extends out of theopening (104) in the housing (102), and is thus extended radially awayfrom the housing (102). FIG. 2B illustrates the electrode (106) in alow-profile or recessed configuration. In the low-profile configuration,the intermediate portion (110) of the electrode (106) is recessed intothe opening (104). As shown, a small portion of the intermediate portion(110) of the electrode (106) may extend slightly radially beyond theouter radius of the catheter housing (102), but in other variations theintermediate portion (110) of the electrode (106) may be flush with orbelow the outer radius of the catheter housing (102). In the low-profilerecessed configuration, the electrode (106) may be able to beatraumatically advanced through vasculature for positioning for fistulaformation. It should be appreciated that in the variation shown in FIGS.2A-2B, the proximal end (108) of the electrode (106) remains fixedrelative to the catheter housing (102) regardless of the position of theintermediate portion (110) and the distal end (112) of the electrode(106).

In some variations, the electrode (106) may be biased toward theextended configuration from the low-profile configuration. That is, theelectrode (106) may be configured to self-expand from the low-profileconfiguration toward the extended configuration. Put yet another way,the electrode (106) may be in its natural resting state in the extendedconfiguration, with the intermediate portion (110) of the electrode(106) extending through the opening (104) in the catheter housing (102)at a predetermined distance away from the outer surface of the catheterhousing (102). In these variations, a force may be required to hold theelectrode (106) in the low-profile configuration. Such a force may be,for example, an external radially inward force applied to theintermediate portion (110) of the electrode (106), or a longitudinalforce applied to an end of the electrode (e.g., a distal end (112) ofthe electrode (106) configured to slide proximally and distally within alumen of the catheter). When an external force is no longer applied tothe intermediate portion (110) of the electrode (106), the electrode(106) may return to the extended configuration such as shown in FIG. 2Aand thereby allow the catheter to be compact. This design may obviatethe need for a complex and/or bulky electrode actuation mechanism.

For example, the electrode (106) may be held in the low-profileconfiguration due to external radially inward force applied by one ormore of a vessel wall (not shown for clarity), second catheter, sheath,or other object that may compress the intermediate portion (110) of theelectrode (106) into the opening (104). Such a force may also cause thedistal end (112) of the electrode (106) to slide longitudinally withinthe housing (102). For example, in some variations, when the catheter(100) is delivered through vasculature to a target location, theintermediate portion (110) of the electrode (106) may contact theinterior surface of a vessel wall. The interior surface of the vesselwall may exert a radially inward force on the intermediate portion (110)of the electrode (106) that forces the electrode (106) into alow-profile recessed configuration in which the electrode (106) isrecessed into the opening (104) while the electrode (106) contacts andadvances through the vessel. The distal end (112) of the electrode (106)may slide distally within the lumen (120) as the intermediate portion(110) of the electrode (106) recesses into the opening (104). As shown,the electrode (106) may comprise a leaf spring—that is, an electrodeformed from a curved slat or ribbon having a curvature configured toflex when an external force is applied against it.

That is, as the electrode (106) of a catheter (100) is advanced througha vessel, the electrode (106) may extend into and out of the opening(104) based on the force encountered. Accordingly, trauma to tissue maybe reduced as the electrode (106) is advanced through a blood vessel.For instance, the electrode (106) may be in the recessed configurationwhile the electrode (106) contacts and advances through a vessel. In therecessed configuration, the electrode (106) may be compressed such thatsubstantially the entire electrode (106) is within the opening (104).The compressed electrode (106) may store energy that allows theelectrode (106) to automatically return to its natural extendedconfiguration once the external force is removed. In some variations, asmall diameter vessel may compress the electrode (106) into the opening(104) while a large diameter vessel may allow the electrode (106) toextend away from the housing (102) before contacting a vessel wall.

The bias of the electrode (106) toward the extended configuration mayincrease the energy efficiency of fistula formation by applying energyto tissue to be ablated rather than to fluid in the vessel. In somevariations, when a leaf spring electrode, as described herein, isenergized and tissue is ablated, the electrode may extend further fromthe opening by virtue of its spring force to maintain continuous contactwith tissue. In this way, the electrode may naturally conform to thesize of the vessel encountered and may eliminate the need for auser-actuated mechanism to deploy and/or extend the electrode from thehousing, while still allowing the catheter comprising the electrode tobe atraumatically delivered through vasculature. Put another way, ratherthan the catheter comprising a user-actuated control that in a firststate holds the electrode in an atraumatic position for delivery throughthe vasculature and in a second state that allows the electrode to entera configuration for tissue ablation, in some variations described hereinthe catheter may not comprise such a user-actuated control. Although theelectrode may be moveable between low-profile and extendedconfigurations, this movement may occur as a natural result of the biasof the electrode in combination with external forces (such as from avessel wall and/or tubular body), and the electrode remains in a singlestate throughout use. That is, during both delivery and tissue ablation,the catheter is in a state in which the electrode would be able to be inthe extended configuration, in the absence of a force external to thecatheter (e.g., from a vessel wall) pressing on the electrode. Put yetanother way, in these catheters described herein, the electrode need notbe released or deployed from a delivery configuration by the user priorto fistula formation. As such, variations of the electrode as describedherein may improve usability by reducing the number of steps andcomplexity of catheter operation, increase catheter reliability byreducing the number of internal moving parts, and simplify cathetermanufacturing by reducing the component count.

In some variations, an ablation surface of the electrode may optionallybe temporarily covered (e.g., by a sheath or tubing) such that theelectrode will not contact tissue and/or other components as it isadvanced through one or more vessels. In these instances, the temporarycovering may be moved, removed, or reciprocated to expose the ablationsurface to the surrounding environment. The covering may slidelongitudinally along an outer surface of the catheter and hold theelectrode in a low-profile configuration. In some variations, atemporary covering disposed over a catheter may aid advancement of thecatheter through an access site (e.g., a hemostasis valve) withoutdamage to either the catheter or access site. For example, a sheathslidably located on a catheter may be configured such that as thecatheter is introduced through a hemostasis valve and into thevasculature, the distal end of the sheath protects the electrode fromcontacting the valve. In this manner, the electrode in a low-profileconfiguration may be covered by the sheath to protect the electrode fromtransitioning into the extended configuration and catching on the valveas it is advanced into a patient. In other variations, the configurationof the electrode as described herein may aid in temporarily coveringand/or packaging a catheter assembly, as the electrode and housing mayadvance as easily through a tubular body (e.g., packaging) as it does ina blood vessel.

FIGS. 3A-3C are detailed depictions of the proximal end (108) of theelectrode (106) at its point of fixation to the catheter housing (102).An electrical lead (130) may be coupled to the proximal end (108) of theelectrode (106). Lead insulation (132) may cover electrical lead (130).A proximal end of the electrical lead (130) may be coupled to an energysource such as a radiofrequency current generator, as discussed indetail herein, to protect against the heat generated when the electrode(106) is activated. The proximal end (108) of the electrode (106) may befixed to the catheter housing (102) in any suitable manner. For example,FIG. 3B illustrates an adhesive (140) applied between the proximal end(108) of the electrode (106), the lead (130), insulation (132), and thehousing (102). The adhesive (140) may protect the insulation (132) fromheat and/or plasma generated from fluid in the opening (104), securelyfix the electrode (106) relative to the housing (102), and/or preventfluid ingress from the opening (104) into other portions of thecatheter. In other variations, the proximal end (108) of the electrode(106) may be mechanically fixed to the housing (102). FIG. 3C provides across-sectional perspective view of the proximal end (108) of theelectrode (106) reducing in width (e.g., tapering) through the housing(102) to further secure and fix the proximal end (108) of the electrode(106) to the housing (102). In some variations, the opening (104) mayform a reservoir for fluid to fill. When the electrode (106) is in anextended configuration, fluid may enter and be held in a reservoirunderneath an outer surface of the electrode (106) and be relativelyundisturbed by fluid flow around the catheter such as blood flow throughthe vessel. As discussed in further detail herein, the electrode (106)may be configured to generate plasma from the fluid in the reservoir.The proximal end (108) of the electrode (106) may be sealed from anyfluid ingress from the reservoir such as through adhesive (140).

In variations in which the distal end of the electrode is configured toslide within the catheter in order to transition the electrode betweenlow-profile and extended configurations, the distal end of the electrodemay comprise one or more features that allow it to move smoothly withinthe catheter. The distal end of the electrode may move longitudinallybetween a first, proximal position when the electrode is in an extendedconfiguration and a second, distal position when the electrode is in alow-profile configuration. For example, as shown in most clearly in FIG.4, the distal end (112) of the electrode (106) may comprise a shape,such as a bend and/or an upturned shape. The distal end (112) of theelectrode (106) may be shaped to promote smooth sliding of the distalend (112) of the electrode (106) within the lumen (120) of the housing(102) without catching or snagging. In the variation shown, the distalend (112) of the electrode (106) is curved, such that the curve movesalong the wall of the lumen (120), rather than the tip of the distal endof the electrode (106) contacting the wall of the lumen (120). In othervariations, the distal end (112) of the electrode (106) may have otherconfigurations in order to allow for smooth translation within thelumen. For example, the distal end (112) of the electrode (106) and/or awall of the lumen (120) may comprise a lubricating coating. The lumen(120) of the electrode (106) may extend distally from the opening (104)and have a length configured to accommodate a full distal extension ofthe distal end (112) of the electrode (106) when in a low-profileconfiguration (i.e., the intermediate portion (110) of the electrode(106) is recessed within the opening (104)).

While a catheter may comprise an electrode having a fixed proximal endand a movable distal end, it should be appreciated that in somevariations, one or more ends of the electrode may be partially fixed,such that the end may translate within a fixed range of motion. FIG. 5is a detailed perspective view of a variation of a distal end of anelectrode (504) having a distal end with a fixed range of motion. Shownthere is a portion of a catheter housing (500) having an opening (502)through which the electrode (504) may extend in the extendedconfiguration. The distal end of the electrode (504) is coupled to ananchor (506) via an elongate fenestration (508). As shown in FIG. 5, theanchor (506) may comprise a pin fixedly attached to a distal end of thehousing (500). The distal end of the electrode (504) may belongitudinally slidable to move the elongate fenestration (508) of theelectrode (504) relative to the anchor (506), such that the fenestration(508) moves between a first position with the anchor at its proximal endand a second position with the anchor at its distal end. The anchor(506) may serve as an axial catch structure to prevent the distal end ofthe electrode (504) from detaching from the housing (500) and passingthrough the housing opening (502).

While in some variations, such as electrode (106) described herein, anintermediate portion (110) of the electrode (106) may have a curvedshape throughout, in other variations, the intermediate portion of theelectrode may comprise one or more discrete bends that allow theelectrode to extend and recess into a housing. For example, FIG. 6Ashows a cross-sectional side view of portion of a catheter comprising ahousing (600) and electrode (604), where the electrode (604) comprises aproximal end (606), an intermediate portion (608) comprising a firstbend (612) and a second bend (614), and a distal end (610). The firstand second bends (612, 614) may have the same or different angles. Asshown, the first bend (612) may be a smaller angle than the second bend(614). In some variations, a leading angle of the intermediate portion(608) of the electrode (604) (e.g., angle of the second bend (614)) maybe maintained at about less than a 40 degree angle with respect to alongitudinal axis of the electrode (604) into the housing (602) when theelectrode (604) transitions between a low-profile configuration and anextended configuration. In some of these variations, the first bend(612) may flatten as the electrode (604) transitions from the extendedconfiguration (as shown in FIG. 6A) to the low-profile configuration.The housing (600) may comprise an opening (602), into which theelectrode (604) may recess in the low-profile configuration. In thelow-profile configuration, a distal end (610) of the electrode (604) maymove smoothly through a lumen of the housing (600). In some of thesevariations, the second bend (614) of the electrode (604) may flatten toa lesser extent than the first bend (612) of the electrode (604).

FIG. 6B shows a cross-sectional side view of another exemplary electrode(644) comprising a proximal end (646), an intermediate portion (648),and a distal end (650), where the intermediate portion (650) of theelectrode (644) comprises a single bend (656). The catheter housing(640) may comprise an opening (642), into which the electrode (644) mayrecess in the low-profile configuration. In some variations, the bend(656) may flatten as the electrode (644) transitions from the extendedconfiguration (as shown in FIG. 6B) to the low-profile configuration. Asshown in FIG. 6B, the bend (656) may be located substantially in thecenter between the proximal end (646) and distal end (650) of theelectrode (644). In the low-profile configuration, a distal end (650) ofthe electrode (644) may move smoothly through a lumen of the housing(640). It should be appreciated that the bend (656) may be located at asuitable location along the intermediate portion (650) of the electrode(644) such as closer to a proximal end (646) or distal end (650) of theelectrode (644).

FIG. 6C is a perspective view of another variation of a bent electrode.The electrode (668) includes a first bend (678) and a second bend (680),where the angles of the first bend (678) and second bend (680) areapproximately equal and the portion of the electrode (668) between thefirst and second bends (678, 680) is substantially parallel to alongitudinal axis of the catheter. When the electrode (668) is in alow-profile configuration, it may recess into the opening (662) of thecatheter housing (660). In some variations, the first and second bends(678, 680) may flatten as the electrode (668) transitions from theextended configuration (as shown in FIG. 6C) to the low-profileconfiguration. The first bend (678) may be located closer to a proximalend of the electrode (668) and the second bend (680) may be locatedcloser to a distal end of the electrode (668). The distance between thefirst and second bend (678, 680) may correspond to an electrode ablationsurface and a length of a fistula formed by the electrode (668). Thecatheter housing (660) may further comprise a first portion of acoaption region (682) and a second portion of the coaption region (684)with the opening (662) therebetween. The coaption region may aid in thevisualization and positioning of one or more catheters relative to eachother and their corresponding blood vessels, as will be discussed inmore detail herein.

It should be appreciated that an electrode is not limited to one or twobends, and an intermediate portion of the electrode may comprise aplurality of bends. In general, the shape of the electrode may beconfigured to allow the electrode to extend to a maximum extendedconfiguration (i.e., radially away from the outer surface of thecatheter) while also being able to recess fully into a low-profileconfiguration (i.e., into an opening in the catheter housing, such thatthe outer surface of the electrode is flush with or below the outersurface of the catheter) without permanently deforming (e.g., retainingits shape memory) and configured to withstand proximal to distal anddistal to proximal insertion into a tubular body (e.g., movement of thecatheter proximally or distally within a vessel) without decoupling theelectrode from the catheter.

The electrodes discussed herein may be made from any suitable materialor combination of materials. In some variations the electrode maycomprise one or more refractory metals. For example, an electrode maycomprise tungsten, molybdenum, niobium, tantalum, rhenium, combinationsor alloys thereof.

While the catheters shown in FIGS. 1A-6C have a single electrode, acatheter may have any suitable number (e.g., zero, one, two, three, orfour or more) and combinations of the electrodes as described herein.The electrodes may be located in or on any suitable portion of thecatheter (e.g., a distal end, an intermediate portion, or combinationsthereof). In variations in which a catheter comprises two or moreelectrodes, multiple electrodes may be used to create multiple fistulas,either simultaneously or sequentially. In other variations, multipleelectrodes may interact to form a single fistula.

2. Fixed Height Electrode

It should be appreciated that in other variations, the fistula-formingelements described herein need not extend into and out of an opening ina catheter housing. In some variations, the devices described herein mayinclude a fixed or static electrode. FIGS. 7A-7B are illustrativedepictions of a portion of a catheter comprising a fixed electrode. Asshown, the catheter may comprise a fixed electrode (712). At least aportion of the electrode (712) may extend radially away from the outersurface of the catheter housing (700), such that it can contact or pressinto tissue to be ablated. In the variation shown, the electrode (712)may comprise a wire having proximal end (706) attached to the catheter,a distal end (710) attached to the catheter, and an intermediate portion(708) between the proximal and distal ends that is at a fixed distanceaway from the outer surface of the catheter.

In some variations of catheters comprising a fixed electrode, a portionof the electrode may be supported by a protrusion of a catheter. Forexample, housing (700) may comprise a protrusion (702) that protrudesfrom the housing (700) by a predetermined amount to support anintermediate portion (708) of the electrode (712). In some variations,the protrusion (702) may extend by up to about 3 mm from the housing(700). The intermediate portion (708) of the electrode (712) may sit onthe protrusion (702). The protrusion (702) may prevent the electrode(708) from deforming under compression. In some variations, on the sideof the catheter opposing the protrusion (702) and intermediate portion(708), the housing (700) may comprise a recess (704) to maintain anapproximately consistent cross-sectional diameter of the catheter alonga length of the housing (700). For instance, the depth of the recess(704) may correspond to a height of the protrusion (702). This may help,for example, the entire catheter to pass through an introducer sheath.In some variations, the recess (704) may be electrically insulated viaepoxy.

3. Shape

The size, shape, and orientation of an electrode used to form a fistulamay determine the size or other characteristics of the fistula,including the fistula resistance and flow rate. The electrode ablationsurface may have any shape or size suitable for ablating tissue andforming a fistula of a desired size and shape. For example, an electrodeablation surface of greater width may generate a wider fistula aperture,resulting in decreased fistula resistance and improved flow. The shapeof the electrode may in some instances be selected to promote woundhealing, as well as to prevent undesirable fistula dilation and othercomplications. In some variations, a desired electrode shape having adesired width may be etched and then formed into a leaf spring. In somevariations, a secondary electrode shape may be welded to an electrode toprovide a desired shape and width to a formed fistula.

In some variations, a portion of an electrode may comprise a rolledportion of material (e.g., a flattened ribbon) configured to contacttissue for fistula formation, while a different portion of the electrodemay comprise an unrolled portion (e.g., a round wire). The rolledportion may be flattened relative to the unrolled portion. For example,returning to FIG. 1B, the intermediate portion (110) and distal end(112) of the electrode (106) may comprise a rolled portion of material(e.g., flattened ribbon) while the proximal end (108) of the electrode(106) may comprise an unrolled portion. In some variations, the proximalend (108) of the electrode (106) may comprise a transition from theunrolled portion to the rolled portion. The distal end (112) of theelectrode (106) may optionally comprise a transition from rolledmaterial to unrolled material (not shown). Similarly, while theelectrode (912) in FIGS. 7A-7B is shown as an unrolled wire, it shouldbe appreciated that in some variations all or a portion of the electrode(712) may be rolled.

FIG. 8 is a plan view of a variation of a rolled portion of an electrode(800). As shown there, the rolled portion of the electrode (800)comprises a proximal end (802), an intermediate portion (804), and adistal end (806). In some variations, a proximal end (802) may comprisea fixing portion (808) to fix the proximal end (802) relative to acatheter housing (not shown). The rolled portion of the electrode (800)may comprise a flat ribbon shape. The electrode (800) may vary in widthalong its length where, for example, an intermediate portion (804) iswider than a proximal end (802) and/or a distal end (806). Theintermediate portion (804) of wider width may correspond to an ablationsurface that contacts and ablates tissue. The electrode may comprise,for example, a ribbon of tungsten or tungsten rhenium formed in a leafspring configuration. In some variations, the intermediate portion of anelectrode may be formed with one or more shapes to aid in formingfistulas having a predetermined configuration. For example, a secondaryelectrode, such as those illustrated in FIGS. 9A-9P may be welded to anintermediate portion (804) of the electrode (800).

FIGS. 9A-9P illustrate exemplary variations of electrode shapes that maybe desirable for fistula formation. Exemplary electrode shapes mayinclude a longitudinally extending bar (902, 904, 906) shown in FIGS.9A-9C, a laterally extending bar (908, 910, 912) shown in FIGS. 9D-9F,one or more circles (914, 916) shown in FIGS. 9G-9H, a dumbbell (918,928) shown in FIGS. 9I, 9N, an asterisk (920) shown in FIG. 9J, ahorseshoe (922) shown in FIG. 9K, a plus sign (924) shown in FIG. 9L, aY-shape (926) shown in FIG. 9M. An exemplary electrode (932) having aplurality of triangular apertures (930) is shown in FIG. 9O. Anotherexemplary electrode (934) having a circular distal end and asemi-circular aperture (936) is shown in FIG. 9P. These shapes may beprovided on a surface of the fistula forming element on a side oppositea catheter opening.

In some of these variations, these shapes may be welded or formed on theelectrode. For example, electrode shapes may be welded to an ablationsurface of an electrode, such as an intermediate portion (804) of theflat ribbon electrode (800) of FIG. 8. FIG. 10A is an exemplarydepiction of the electrode shape of FIG. 9L welded to the electrodedepicted in FIG. 8. In particular, FIG. 10A illustrates a flat ribbonelectrode (1000) having a plus shaped electrode (1002) welded thereon.In variations of systems described herein comprising first and secondcatheters both comprising an electrode, both electrodes may have thesame shape. In others of these variations, an electrode of one cathetermay be configured to nest with an electrode of the other catheter. Inyet others of these variations, electrodes of both catheters may havesimilar shapes, but one electrode may be larger than the other. This maybe desirable, for example, for making a larger opening in a first vessel(e.g., a vein) than in a second vessel (e.g., an artery). It should benoted that in some instances, fistula dilation may be reduced by forminga fistula in a circumferential direction of a blood vessel as opposed toan axial direction. For example, as shown in FIG. 10B, a shape may bewelded or formed on an electrode having a lengthwise directionperpendicular to the longitudinal axis of the catheter. FIG. 10B is anexemplary depiction of the electrode shape of FIG. 9N welded to theelectrode depicted in FIG. 8. In particular, FIG. 10B illustrates a flatribbon electrode (1010) having a dumbbell shaped electrode (1012) weldedthereon.

In some variations, the electrode shape may be configured to havebeneficial effects. For instance, an electrode may be configured to formtissue flaps. These tissue flaps may facilitate neointimal generationthrough the extravascular space and may promote wound healing and reducethe likelihood of thrombosis. Exemplary electrode shapes that may formtissue flaps include an asterisk shape (920), plus shape (924), orY-shape (926), as shown in FIGS. 9J, 9L, and 9M, respectively. Forinstance, FIG. 11A shows a side view of a fistula (1108) formed using anelectrode having a plus shape, such as an electrode comprising the plusshape (924) shown in FIG. 9L. FIG. 11B shows a cross-sectional view oftwo vessels (1104, 1106) between which the fistula (1108) is formed. Asshown in FIGS. 11A-11B, the fistula (1108) may form tissue flaps (1102).As shown in the cross-sectional view of FIG. 11B, the tissue flaps(1102) may fold over from the first vessel (1104) into the second vessel(1106) when a fistula (1108) is formed. As another example, theelectrode shape may be configured to form a fistula with a shapeconfigured to distribute fluid flow strain across a wider surface areato prevent undesirable fistula enlargement, dilation, or tearing due toarterial blood pressure. For example, FIG. 12A illustrates a side viewof a fistula (1200) with strain relief ends (1202) formed by anelectrode comprising a dumbbell shape with rounded ends as shown in FIG.9N. FIG. 12B illustrates a side view of a fistula (1204) with strainrelief ends (1206) formed by an electrode comprising a dumbbell shapewith flat ends as shown in FIG. 9I.

A size (e.g., radius) and shape of tissue ablation created using a givenelectrode may depend not only on the size and shape of the electrode,but also on the energy delivered to the electrode and adjacent tissueand/or fluid. For example, a lower voltage may ablate tissue to form acut that corresponds to the shape of the electrode, while a highervoltage may increase an ablation radius of the electrode, such that theablated area is larger than the electrode. In some variations, energymay be applied such that the fistula does not exceed the dimensions ofthe electrode by more than about 0.1 mm.

In some variations, an electrode may have one or more apertures orrecesses, such that energy applied to the electrode to ablate tissue mayablate an outer circumference of tissue while generally leaving intactone or more inner tissue portions within the outer circumference. Invariations having recesses, the recesses may vary in height. Afterinitial formation of the fistula with the electrode, blood flow throughthe fistula may naturally push the inner tissue portions out of thefistula. An exemplary electrode (932) having a plurality of triangularapertures (930) is shown in FIG. 9O. In some of these variations, it maybe desirable that the aperture be about 0.07 mm or less in diameter toprevent the separated tissue released into the bloodstream from formingan embolism. In the electrode (934) shown in FIG. 9P, the aperture (936)may comprise asperities that may aid bubble formation and createelectric field concentrations in the electrode, thereby increasing thelocal current densities and increasing localized resistive heating. Thismay speed up ablation by reducing a vapor generation time precedingplasma generation.

C. Single-Sided Electrode Systems

In the systems described herein comprising two catheters, each cathetermay comprise a fistula-forming element, but need not. In somevariations, only one catheter may comprise a fistula-forming element. Insome of these instances, a second catheter that lacks a fistula-formingelement may not directly ablate tissue, but may help align thecatheters, bring the blood vessels into apposition, and/or otherwiseimprove formation of a fistula. Generally, in these variations, thesecond catheter may comprise a backstop configured to be positionedwithin a vessel such that the backstop opposes a fistula-forming elementof the first catheter. The backstop of a second catheter may protrudefrom one side of the second catheter body. In some variations, thebackstop may have a shape corresponding to a fistula-forming element ofa first catheter to extend into the second catheter, which may in someinstances increase an ablation surface and therefore a length of afistula. For example, the backstop may comprise one or more concave orconvex portions configured to be corresponding and complementary to thefistula-forming element of the first catheter. In some variations, thesecond catheter may comprise a recessed portion on the opposite side ofthe catheter body from the backstop. In some variations, a cathetercomprising a protruding backstop may encounter difficulty passingthrough a tubular body such as an introducer sheath. A recessed portionmay define a relief cut to accommodate passage of the catheter through atubular body such as an introducer sheath. This may allow an approximatecross-sectional diameter of the catheter to be maintained through theregion comprising the backstop. In this way, a catheter may be able tofit through a lumen of an introducer sheath and/or a blood vessel, sincethe diameter of a catheter may not exceed, even at the location of thebackstop, a lumen diameter of an introducer sheath and/or blood vessel.

The backstop may be configured to compress tissue in a localized regionfor ablation by a fistula-forming element of a first catheter.Compressing tissue between a backstop and a fistula-forming element mayreduce the required height or ablating reach of the fistula-formingelement. The backstop may comprise any suitable nonconductive material.For example, the backstop may comprise a ceramic and/or polymericmaterial.

FIG. 13A depicts a portion of a second catheter comprising a protrudingbackstop (1302) having a flat surface protruding from a square secondcatheter (1300). FIG. 13B shows the backstop (1302) aligned with anelectrode (1306) of a first catheter (1304). In use, after advancementof the first and second catheters into respective blood vessels (notshown), the catheter housings may be aligned as shown in FIG. 13B. Theconvex portion (1302) of the second catheter (1300) may oppose theelectrode (1306) and compress tissue therebetween. As shown anddiscussed in more detail herein, the size and shape of a backstop may bevaried based on factors including tissue thickness and density, as wellas a desired fistula size, shape, and location.

FIGS. 14A-14B show perspective and side views, respectively, of aportion of a second catheter (1400) comprising a protruding backstop(1402). Opposite the backstop (1402), the second catheter comprises arecessed portion (1404) having a complementary shape to the protrudingbackstop (1402). FIG. 14C shows a portion of the second catheter (1400)aligned with a portion of a first catheter (1406) comprising anelectrode (1408). In some variations, the protruding backstops (1302,1402) may aid ablation of thicker tissue by further compressing tissueagainst the electrode (1306, 1408).

FIGS. 15A-15B depict a protruding backstop having a complementary shapeto a corresponding electrode. A system is shown there comprising a firstcatheter (1504) comprising an electrode (1506) and a second catheter(1500) comprising a protruding backstop (1502). The backstop (1502)comprises a concave portion having a shape that is a corresponding andcomplementary (e.g., inverse, reciprocal) for matching or conforming tothe electrode (1506) when the first and second catheters (1504, 1500)are aligned. As shown best in FIG. 15B, the shape of the concave portionof the backstop (1502) may correspond to a shape of the intermediateportion of the electrode (1506) in an extended configuration. As such,when the first and second catheters (1504, 1500) are located in adjacentvessels and properly aligned, the backstop (1502) may promote tissuecompression between the backstop (1502) and the electrode (1506). Whileshown in FIGS. 15A-15B as comprising a concave curved portion, in othervariations, a backstop may have any suitable shape based on the shape ofan electrode, such as, for example, a complementary shape to theelectrodes depicted in FIGS. 6A-6C. In some variations, such as shown inFIGS. 15A-15B, the lowest point of the concave portion may beapproximately at the same height as the catheter body adjacent to thebackstop. However, it should be appreciated that in other variations,the lowest point of the concave portion may be below the height of thecatheter body adjacent to the back stop—i.e., in some variations thebackstop may be partially protruding and partially recessed.

While FIGS. 13A-15B show backstops protruding from a second catheter, inother variations, the backstop may be recessed into the catheter, or thebackstop may have some portions extending from and some portionsrecessed into the catheter. For example, FIG. 16 shows a catheter systemcomprising a catheter with a recessed backstop having a complementaryshape to a portion of an electrode of another catheter. Shown there is across-sectional side view of a system comprising a first catheter (1604)comprising a curved electrode (1606) and a second catheter (1600)comprising a curved, concave recessed backstop (1602). The concavebackstop (1602) may have a complementary (e.g., inverse, reciprocal)shape matching or conforming to a portion of the electrode (1606) of thefirst catheter (1604).

In variations of a system comprising a backstop having a complementaryshape to a corresponding electrode (e.g., FIGS. 15A-16), a length of afistula formed may be based on a length of the corresponding regions ofthe backstop and electrode, i.e., a compression region of the backstop.For example, in the variation of FIGS. 15A-15B, the fistula formed bythe system may have a length corresponding to the peak-to-peak distanceof a saddle shape formed by the backstop, shown in FIG. 15B as distance1508. As another example, in the variation of FIG. 16, the fistulaformed by the system may have a length corresponding to the end-to-enddistance of the recess, shown in FIG. 16 as distance 1608.

In other variations, second catheters described herein may compriserecessed backstops not having a complementary shape to the electrode ofan opposing first catheter. For example, in some variations, a secondcatheter may comprise a rectangular recess configured to receive aportion of an electrode of an opposing first catheter during or afterfistula formation. An exemplary recessed backstop (1702) is shown inperspective and cross-sectional views in FIGS. 17A and 17B,respectively. As shown there, the recess (1702) may comprise arectangular recess (e.g., slot) to receive a portion an electrode. Anexemplary system comprising the recessed backstop (1702) is shown inFIG. 17C, comprising a first catheter (1704) comprising a curvedelectrode (1706), and a second catheter (1700) comprising therectangular recessed backstop (1702). The portion of the electrode(1706) radially furthest from the first catheter (1704) may fit into therectangular recess. As such, the width of the slot may be configured tobe at least the width of the electrode (1706).

A rectangular recessed backstop may have any suitable length and depth.FIGS. 18A-18B are cross-sectional views of two systems comprising afirst catheter with an electrode and a second catheter with arectangular recessed backstop. FIG. 18A shows a variation comprising afirst catheter (1804) comprising a curved electrode (1806), and a secondcatheter (1800) comprising a backstop comprising a rectangular recess(1802). FIG. 18B shows the first catheter (1804) of FIG. 18A with adifferent second catheter (1810). As shown there, the second catheter(1810) comprises a backstop comprising a rectangular recess (1812),where the rectangular recess (1812) is shorter and shallower than therectangular recess (1802). As such, a smaller portion of the electrode(1806) is able to be received by the recess (1812) as compared to therecess (1802). This may result in formation of a smaller fistula whenformed by delivering current from the electrode (1806). More generally,second catheters comprising backstops with recesses having differentdepths and/or lengths may allow for the generation of fistulas ofdifferent dimensions when using the same electrode. A deeper recess mayallow a larger portion of the electrode to extend into the recess, thusincreasing an ablation surface of the electrode. In some non-limitingvariations, the backstop may be between about 2 mm and about 20 mm inlength, and the recess may be between about 1 mm and about 10 mm inlength. In one variation, the backstop may be about 10 mm in length.

In single-sided electrode systems, a first catheter comprising anelectrode may be connected to a monopolar output of a current generator.In some variations, a single-sided electrode system may comprise one ormore return electrodes (e.g., ground pads) that may be disposed on askin of a patient and configured to allow current to pass from an activeelectrode of the first catheter through the patient and then to thereturn electrode. A conductive gel may be applied between the returnelectrode and the skin to improve contact.

D. Dual-Sided Electrode Systems

In other variations, the catheter systems described herein may bedual-sided catheter systems. A dual-sided catheter system may comprisefirst and second catheters each including one or more electrodes. Insome variations, the dual-sided catheter systems may be dual-ablationcatheter systems, wherein one or more electrodes on each of the twocatheters delivers energy for ablating tissue at a fistula site fromopposing sides such that the electrodes on each catheter are activeelectrodes and deliver current. In order to both deliver energy, bothcatheters may be connected to an active output of a current generator. Adual-ablating system may comprise one or more return electrodes (e.g.,ground pads) that may be disposed on a skin of a patient and configuredto allow current to pass from the active electrodes through the patientand then to the return electrode. A conductive gel may be appliedbetween the return electrode and the skin to improve contact. A dualablating system as described herein may have the ability to ablatethrough twice as much tissue in a predetermined amount of time ascompared to a single-sided ablation system. The energy applied to tissuemay also be distributed more evenly when delivered with a dual-ablationsystem. In other variations, the dual-sided catheter systems may beconfigured such that one or more electrodes on one of the two cathetersdeliver energy, wherein one or more electrodes on the second of the twocatheters provides a return path.

FIGS. 19A-19D are illustrative depictions of a distal portion of avariation of a dual-sided catheter system comprises a first catheter(1900) and a second catheter (1910) comprising a respective firstelectrode (1902) and second electrode (1912). The electrodes (1902,1912) may have a low-profile configuration and an extendedconfiguration, and may be biased toward the extended configuration, asdescribed in more detail herein. As shown in FIGS. 19A-19D, eachelectrode may comprise a curved wire configured to at least partiallyflatten in the low-profile configuration, as described in more detailherein. In some variations, each electrode may include, for example, acantilevered leaf spring element that may deflect to recess into itsrespective housing and may extend outward once energized to ablatetissue and cut through tissue, similar to the other leaf springelectrodes described herein. The leaf spring may be thin enough suchthat if the electrodes abut against each other, the leaf spring willconform to a flat mating surface.

Fistula formation using two such catheters may be achieved in multipleways, including, for example, in either monopolar or bipolarconfigurations. In some variations when both catheters are designed formonopolar energy delivery, current may be delivered by the firstelectrode (1902) at the same time as the second electrode (1912). Inother variations, the first electrode (1902) may be an active electrodeand the second electrode (1912) may be a return electrode, or viceversa. In yet other variations, the first electrode (1902) may beactivated and followed by the second electrode (1912), or vice versa. Insome variations a combination of these modes may be combined oralternated. In some variations, the electrodes may be activated inalternation, for example for a fixed number of cycles. The electrodesmay have the same or different shapes, widths, and geometry. It shouldbe appreciated that any combination of electrode and catheter designsdescribed herein may be used in the dual-sided electrode systemscontemplated herein.

E. Synergistic Ablation Systems

In other variations, the catheter systems described herein may beconfigured for synergistic ablation. Synergistic ablation as referred toherein means tissue ablation through one blood vessel that relies ontissue ablation through another blood vessel. For instance, synergisticablation may begin by ablating tissue with a first catheter disposed ina first blood vessel. Once a predetermined amount of tissue is ablated,a second catheter disposed in a second blood vessel may provideconcurrent tissue ablation until fistula formation is complete. In thismanner, tissue ablation may begin with one catheter but be subsequentlycombined with tissue ablation from a second catheter. As described indetail herein, synergistic ablation may improve the safety and increasethe speed of fistula formation, and may be provided by a compact system.

More particularly, in synergistic ablation, tissue ablation may beperformed in a first blood vessel by a first catheter for apredetermined period of time and is followed by tissue ablationperformed in a second blood vessel by a second catheter in conjunctionwith tissue ablation by the first catheter. For example, a firstcatheter may comprise an electrode that acts as an active electrode,while a second catheter may comprise a conductive material thatactivates only upon contact with the electrode of the first catheter.The electrode of the first catheter may be energized by a power sourceto perform tissue ablation. Once sufficient tissue is ablated from theblood vessels, the electrode of the first catheter may make physicalcontact with the conductive material of the second catheter such thatthe conductive material is energized by the power source through contactwith the electrode of the first catheter. It should be noted that evenwhen the conductive portion is not energized, the conductive portion maystretch and/or compress tissue to improve tissue ablation by anelectrode of the first catheter.

FIGS. 20A-20D are illustrative depictions of portions of a systemincluding a first catheter (2006) comprising an electrode (2008) and asecond catheter (2000) comprising a conductive portion (2002). FIG. 20Ais a perspective view of a portion of the second catheter (2000). FIGS.20B-20D show cross-sections of a portion of the first (2006) and second(2000) catheters disposed in blood vessels (2010, 2012). The firstcatheter (2006) may comprise an active electrode (2008) coupled to apower source (not shown). The second catheter (2000) may comprise anelectrically conductive portion (2002), configured to be contacted bythe electrode (2008). FIGS. 20C-20D are cross-sectional side views ofthe first catheter (2006) and second catheter (2000) disposed in bloodvessels (2010, 2012). Upon activation of the electrode (2008), theelectrode may generate plasma and the tissue adjacent to the activeelectrode in a first blood vessel (2012) may be ablated (FIG. 20C). Theactive electrode (2008) may advance through the walls of the first andsecond vessels to contact the electrically conductive portion (2002) ofthe second catheter (FIG. 20C). Contact between the two electricalsurfaces may serve to electrically connect the active electrode (2008)to the electrically conductive portion (2002) such that they generallyshare the same electrical potential, and the electrically conductiveportion (2002) serves as an extension of the electrode (2008).Subsequent to contact, energy supplied from the power source may conductdirectly into the electrically conductive portion (2002), therebypromoting the formation of a plasma on the electrically conductiveportion (2002). This may serve to ablate or further remove tissue thatthe conductive portion (2002) is in contact with from within the secondblood vessel (2010), until the electrode (2008) has traveled fullythrough the walls of both vessels and rests against the conductiveportion (2002) (FIG. 20D). In this way, a single electrical source mayconduct energy into two separate electrodes in a system, the secondelectrode of which activates only when the first forming element hasestablished contact.

It should be appreciated that the conductive portion of the secondcatheter may have any suitable shape. That is, the conductive portion isnot particularly limited in size and shape and may comprise a spring, araised wire, and/or a rigidly fixed metallic surface. FIGS. 21A-21Edepict side views of several variations of the conductive portiondisposed on various catheters (2100, 2102, 2104, 2106, 2108), includinga flat conductive portion (2112) as shown in FIG. 21A, a protrudingconductive portion having a first and second bend (2114) as shown inFIG. 21B, a rounded conductive portion (2116) as shown in FIG. 21C, aprotruding conductive portion having a one bend (2118) as shown in FIG.21D, and a protruding conductive portion having a projection (2120) asshown in FIG. 21E. It should be appreciated that any combination ofelectrode designs described herein may be used in the synergisticablation systems contemplated herein.

In some variations, the first catheter (2006) and second catheter (2000)shown in FIG. 20A-20D may be used to form an arteriovenous fistula byfirst ablating tissue from the venous side of a coapted artery-veinpair. Once a hole has been produced by the advancing electrode (2008)coming from the venous side, the arterial portion (2002) may be made toactivate via electrical contact with the active electrode (2008) tofurther remove tissue on the arterial side. Synergistic ablation in thismanner may prevent incomplete fistula formation due to a breach in thearterial wall when fistula formation begins from an arterial side. Forinstance, arterial ablation may be activated only when the conductiveportion (2002) directly contacts the electrode (2008) from the venousside, which occurs only if a hole is formed from the venous lumen to thearterial lumen. Thus, the risk of high-flow arterial blood undesirablyincreasing the size of a fistula is reduced.

In some variations, synergistic ablation may enable enlargement of thefistula aperture using a leaf spring electrode of a first catheteradvancing from a venous side of a coapted artery-vein pair. Where theconductive portion is energized by the electrode, the conductive portionneed not include wires or other elements through the second catheter toenergize the conductive portion. In some variations, a conductiveportion of a second catheter opposing an electrode (e.g., leaf springelectrode) may be free of electrical components within the proximalsection of the catheter (e.g., power source and wire to energize theconductive portion). Accordingly, a proximal coaption region of thesecond catheter comprising a set of magnets may be provided with moremass and attractive force, thus increasing tissue compression andcatheter alignment. Additionally or alternatively, the second cathetermay be formed with a smaller diameter relative to the first catheter orother alignment elements relative to the first catheter.

F. Energy Source

As described herein, the electrodes described herein may be connected toa radiofrequency current generator (e.g., via the monopolar or bipolaroutput of the current generator) to energize the electrodes for thevarious applications described herein (e.g., blood vessel modification,tissue ablation). The electrodes may be advanced into a first bloodvessel adjacent a second blood vessel, and in some of these variations,a ground electrode may be placed external to the patient, and currentmay be applied to the tissue via the electrode to form a fistula betweenthe two vessels. The tissue of a first blood vessel, being locatedcloser to the electrode, may be ablated or vaporized more quickly thantissue of a second blood vessel. Additionally, in variations where theelectrode is configured to extend through tissue while ablating, theelectrode may first contact and ablate tissue of the first blood vesselprior to contacting and ablating tissue of the second blood vessel.

In some variations, one or more electrodes may be connected to anelectrosurgical generator, power supply, or other waveform generatorthat is configured to generate an alternating current under the controlof an electrosurgical controller. In some of these variations, one ormore electrodes may be connected to a monopolar output of a generator.In other variations, two or more electrodes may be connected to thebipolar outputs of a generator. In some of these variations, a firstelectrode is attached to the active output of the generator, and areturn electrode (e.g., a large metal plate or flexible metalized pad)may be temporarily attached or affixed to the patient and connected tothe return output of the generator. In others of these variations, twoor more electrodes may be attached to an active output of the generator,and a return electrode may be temporarily attached or affixed to thepatient and connected to the return output of the generator. In stillother variations, a first electrode may be attached to the active outputof the generator, and a second electrode may be attached to the returnoutput of the generator. In yet other variations, a first electrode maybe connected to an output of a generator and a second electrode may befloating, that is, not directly connected to any output of thegenerator, in a focused monopolar configuration.

In some variations, the radiofrequency current generator may be a highvoltage generator having a voltage range from about 180 V peak and about500 V peak and a frequency range between about 150 kHz and about 8 MHz.The generator may be configured to generate, for example, sinusoidal andsquare waveforms.

G. Alignment Features

In variations in which a system having multiple catheters is used tocreate a fistula between two blood vessels, each catheter may beconfigured to promote rotational and/or axial alignment. Proper axialand rotational alignment between two catheters may facilitate alignmentof one or more fistula-forming elements on a first catheter with one ormore corresponding elements (e.g., one or more fistula-forming elements,one or more corresponding surfaces (e.g., a backstop)) on a secondcatheter.

To illustrate axial and rotational alignment, FIG. 22A shows a cathetersystem comprising a first catheter (2200) and second catheter (2210),wherein the catheters are axially aligned such that their respectivefirst electrodes (2202, 2212) may form a fistula from opposing sides ofthe same region of tissues (not shown for clarity). By contrast, FIG.22B illustrates the first catheter (2200) and second catheter (2210)axially misaligned such that their respective first electrode (2202) and(2212) contact tissues at two different axial locations along thevessels.

FIGS. 22C-22D each depict a cross-sectional view of the first catheter(2200) and second catheter (2210) along the A-A line of FIG. 22A. FIG.22C illustrates the first catheter (2200) and the second catheter (2210)rotationally aligned. By contrast, FIG. 22D illustrates the firstcatheter (2200) rotationally misaligned to the second catheter (2210).One or more magnets, flat coaption surfaces, rotational indicators, andhandle features may help to achieve axial and/or rotational alignment,as described in more detail herein.

1. Magnets

As mentioned above, the catheters of the systems described here maycomprise one or more magnets, which may assist with rotational and axialalignment, as well as bring the catheters together to compress tissue.Generally, the magnets may be configured to be attracted to one or moremagnetic fields (e.g., produced by one or more magnets of anothercatheter). The magnets may help to align or otherwise reposition thecatheters when placed in the vasculature. In some instances, a systemmay comprise first and second catheters each having one or more magnets,such that magnets of the first catheter may be attracted to magnets ofthe second catheter to bring the catheters in closer approximation. Theone or more magnets may help to ensure that one or more catheters are inproper axial and/or rotational alignment relative to another catheter orcatheters. Such axial and/or rotational alignment of catheters may alsofacilitate alignment of one or more fistula-forming elements relative toa fistula site.

In variations in which the catheters of the systems described herecomprise one or more magnets, each catheter may have any number ofindividual magnets (e.g., one, two, three, four, five, six, seven, oreight or more, etc.). In variations in which a catheter has a pluralityof magnets, these magnets may be grouped into one or more magnet arrays.The magnets may be located inside and/or outside of a catheter body. Themagnets may be positioned anywhere along the length of the catheter. Insome variations in which a catheter comprises an electrode, an alignmentportion may include one or more magnets proximal to an electrode.Additionally or alternatively, the first catheter may have one or moremagnets distal to the electrode.

The magnets described here throughout may be permanent magnetscomprising one or more hard magnetic materials, such as but not limitedto alloys of rare earth elements (e.g., samarium-cobalt magnets orneodymium magnets, such as N52 magnets) or alnico. In some variations,the magnets may comprise anisotropic magnets; in other variations, themagnets may comprise isotropic magnetics. In some variations, themagnets may be formed from compressed powder. In some variations, aportion of the magnets (e.g., a permeable backing) may comprise one ormore soft magnetic materials, such as but not limited to iron, cobalt,nickel, or ferrite. It should be appreciated that in some variations ofsystems comprising two catheters, either the first or second cathetermay comprise ferromagnetic elements (i.e., elements attracted to but notgenerating a permanent magnetic field). For example, in some variations,the first catheter may include only one or more ferromagnetic elementswhile the second catheter may comprise one or more permanent magnets. Inother variations, the second catheter may include only one or moreferromagnetic elements while the first catheter may comprise one or morepermanent magnets. However, in other variations, one or both of thefirst and second catheters may include any suitable combination offerromagnetic, permanent, and/or other suitable kinds of magnets.

Generally, the dimensions of the magnets described herein may beselected based upon by the size of the catheters carrying the magnets,which in turn may be selected based upon the anatomical dimensions ofthe selected blood vessels through which the catheters may be advanced.For example, if the catheter is to be advanced through a blood vesselhaving an internal diameter of about 3 mm, it may be desirable toconfigure any magnet to be less than about 3 mm at the widest part ofits cross-section, to reduce the risk of injury to vessel walls duringadvancement and manipulation of the catheter. Each magnet may have anysuitable length (e.g., about 5 mm, about 10 mm, about 15 mm, about 20mm, or the like), although it should be appreciated that in someinstances longer magnets may limit the flexibility of the catheter tomaneuver through tissue. Accordingly, in some variations, a pluralitymagnets (e.g., square magnets, as described in more detail herein) maybe arranged in a linear array along the length of a catheter to promoteflexibility of the catheter.

Given the limitations on magnet size, it may be desirable in someinstances to use magnets configured to produce magnetic fields thatincrease the magnetic force that can be generated with a magnet of agiven size. For example, in some variations the system may comprise oneor more of the magnets described in U.S. patent application Ser. No.14/214,503, filed on Mar. 14, 2014, and titled “FISTULA FORMULATIONDEVICES AND METHODS THEREFOR,” and/or U.S. patent application Ser. No.14/657,997, filed on Mar. 13, 2015, and titled “FISTULA FORMATIONDEVICES AND METHODS THEREFOR,” each of which is hereby incorporated byreference in its entirety.

Each magnet may be fixed in or on a catheter by any suitable method. Forexample, in some variations one or more magnets may be embedded in,adhered to, or friction-fit within a catheter.

2. Flat Coaption Surfaces

In general, proper rotational alignment between two catheters may bepromoted by a flat coaption surface. For example, the two catheters mayeach comprise a flat surface configured to be aligned with the flatsurface of the opposing catheter, and in some instances the cathetersmay have a rectangular or square cross-section for all or a portion ofeach catheter's length. In some variations, magnets within the cathetersmay also have a rectangular or square cross-section. These flat surfacesof opposing catheters may help to naturally align the two catheters witheach other. This is similar to the phenomenon that a rigid body placedonto an angled surface will automatically align itself to be parallel tothe surface due to gravitational forces. For instance, when an edge of abox is placed on a flat surface, gravity will produce a moment withrespect to the center of gravity of the box such that the box will fallover and align itself with the flat surface to reach equilibrium.Similarly, magnetic coaption forces may bring two flat magnetic surfacestogether in parallel with each other when brought in close proximity toeach other. As such, flat coaption surfaces may bring a pair ofcatheters into rotational alignment and increase tissue compression toenhance fistula formation.

FIGS. 23A-23D illustrate a system having a first catheter (2300) and asecond catheter (2310) each comprising a flat coaption surface. As shownthere, the catheters (2300, 2310) each comprise a coaption region (2316,2318) in a distal portion of the catheter, where the coaption region hasa square cross-section. As such, one side of each coaption region (2316,2318) forms a flat coaption surface (2306, 2314). When the first andsecond (2300, 2310) catheters are properly aligned as shown in FIGS.23A-23D, the flat coaption surface (2306) of the first catheter facesthe flat coaption surface (2314) of the second catheter (2310).

Each catheter may further comprise magnets within one or more portionsof the coaption regions. In some variations, the first catheter maycomprise one or more magnets proximal to the electrode and one or moremagnets distal to the electrode, and the second catheter may compriseone or more magnets proximal to the backstop (or electrode or conductivecontact in a dual-sided system) and one or more magnets distal to thebackstop (or electrode or conductive contact in a dual-sided system).FIG. 23D is a cross-sectional view of a portion of the catheters (2300,2310), showing a series of square magnets (2320, 2322) in the first andsecond coaption regions (2316, 2318) proximal to the electrode (2304)and backstop (2312), respectively. The magnets (2320) in the coaptionregion (2318) of the first catheter (2300) may comprise a lumen for awire (2308) to electrically couple a power source to the electrode(2304). The wire (2308) may be covered by insulation (2302) to shieldthe magnets (2320) from current carried by the wire (2308).

In FIGS. 23A-23D, where the second catheter (2310) provides a backstop(2312), the magnetic forces of attraction are focused on the backstop(2312), which may increase tissue compression between the backstop(2312) and the electrode (2304). When the first catheter (2300) islocated in a first vessel and the second catheter (2310) is located inan adjacent second vessel and the two catheters are properly aligned,magnetic forces of coaption may compress the electrode (2304) into thevessel tissue (not shown) by bringing the two catheters in closeapproximation, which may improve the ability to make a transmural cut.In addition to bringing the catheters closer together and compressingtissue, flat coaption surfaces may allow a lateral magnetic coaptionforce to be generated. An aligning torque corresponding to an attractivemagnetic force may manifest when the first catheter (2300) and secondcatheter (2300) are rotationally misaligned, which may promote alignmentof the catheters relative to each other. The aligning torque mayincrease as the catheters are brought closer together. Because thestrength of the magnetic forces depends in part on the shape of thecatheter surfaces (e.g., the aligning torque may be greater between apair of flat magnetic surfaces than for a pair of magnetic cylinders),the two catheters each comprising a flat coaption surface may generate agreater aligning torque for a given amount of rotational misalignmentthan two catheters each comprising curved coaption surfaces. Forexample, for a pair of catheters each having a square cross-sectionforming a flat coaption surface, and each having a coaption region ofmagnets of approximately the same dimensions (e.g., diameter andlength), the aligning torque generated between flat magnetic surfaces at5 degrees of misalignment is at least approximately 18 times strongerthan that of the aligning torque between magnetic cylinders.

FIGS. 19C-19D show catheters (1900) and (1910) each comprising acoaption region with a flat coaption surface and an electrode. Thecoaption region may be located proximal and distal to the electrode andmay have a square cross-section in to enhance the ability of thecatheters to come into correct rotational alignment by virtue ofmagnetic aligning torque, as described in more detail herein. The firstcatheter (1900) comprising a first magnet array (1905). The secondcatheter (1910) comprises a second magnet array (1915). As shown, bothcatheters comprise magnet arrays proximal and distal to the electrode.The magnet arrays comprise a plurality of square magnets arrayed in alinear array. The magnets of the magnet arrays proximal to the electrodemay comprise a central lumen therethrough that may allow for travel of alead wire to the electrode. The linear arrangement of square magnetswithin catheters having a square cross-section may allow for improvedrotational alignment, while still allowing for bending of the catheter.In some variations, a catheter may comprise one or more alignmentfeatures to assist with rotationally aligning the catheters, asdescribed in more detail here. For instance, FIG. 19C a first rotationalindicator (1907) (as described in detail herein) between the firstmagnet array (1905) and the first distal end (1908), and a secondrotational indicator (1917) between the second magnet array (1915) andthe second distal end (1918).

The coaption regions may have any suitable length along the catheters.For example, in one non-limiting variation, the coaption regions mayextend about 15 mm distally and proximally from an electrode orbackstop.

Once the first and second catheters have been positioned, the attractiveforce may also act to maintain the relative positions of the catheters.When the first and second catheters are placed in respective bloodvessels, however, tissue positioned between the blood vessels and/orlimited compliance of the blood vessels may limit the extent to whichthe magnets of the first and second catheters bring the first and secondcatheters toward each other. The size and strength of the magnets may beconfigured to provide a desired level of tissue compression, asdescribed herein.

3. Visual Alignment Aids

In some variations, the catheters described herein may comprise visualalignment aids for indirectly visualizing alignment of catheters withrespect to each other. Rotational alignment of the catheters may bedifficult to discern. Fluoroscopically visualized rotational indicators,as described in detail herein, enable better rotational alignment ofcatheters relative to each other, and may also help with axialalignment.

A visual alignment aid may be visualized using a technique such asfluoroscopy during positioning and/or alignment of a catheter system.Fluoroscopy is a technique for real-time X-ray imaging and may be usedto guide catheter insertion and movement through blood vessels.Generally, in fluoroscopy, an X-ray beam is emitted from a fluoroscopethrough an area of interest in a body. Objects to be visualized (e.g.,catheters) may be imaged using an image intensifier. A user viewing thereal-time images shown by the image intensifier may then determine theorientation and alignment of the catheters relative to each other.However, due to the two-dimensional nature of the X-ray imagesgenerated, some fluoroscopic visualization techniques may not be idealfor determining the three-dimensional orientation of one or morecatheters. Thus, a rotational indicator may serve as a visual marker forguiding rotational alignment of two catheters as viewed underfluoroscopy. In some variations, when used in conjunction with a secondcatheter (not shown) having a second rotational indicator, therotational indicators of each catheter may be used to rotationallyand/or axially position the catheters relative to each other such thatthat one or more fistula-forming elements may be properly positioned toform a fistula. In some variations, a first catheter and a secondcatheter may each include identical rotational indicators having aradiopaque film. Imaging of rotational indicators having the same widthand shape under fluoroscopy indicates rotational alignment of the firstand second catheters relative to each other. Rotational indicatorsappearing the same under fluoroscopic visualization in adjacentcatheters are aligned with respect to each other and indicate properalignment for fistula formation. Accordingly, the catheters may befluoroscopically aligned to each other rather than aligned to an X-raybeam.

Generally a rotational indicator may be configured such that itsrotational orientation is discernable in a two-dimensional fluoroscopicimage. One example is shown in FIGS. 24A-24B. FIGS. 24A-24B is arecross-sectional views of a catheter comprising a rotational indicatorcomprising a thin radiopaque film (2402) in a first rotationalorientation parallel to an X-ray beam (2406) (FIG. 24A), and in a secondrotational orientation rotated relative to the X-ray beam (2406) (FIG.24B). The radiopaque film (2402) may block X-rays emitted from afluoroscope to produce a shaded area when visualized on a user display(e.g. image intensifier). The width of the resulting shaded area,represented by width W between dashed lines in FIG. 24B, may correspondto an angular rotation of the catheter relative to the X-ray beam and isgiven by 2r sin(θ), where r is the thickness of the film and θ is theangle between the film and the X-ray beam. The radiopaque film (2402)may be configured to be very sensitive to rotational misalignment toallow for high precision rotational positioning. In some instances, avery thin (e.g., 0.025 mm thick) radiopaque film (2402) in parallel tothe X-ray beam (FIG. 24A) may not be visible under fluoroscopy and mayindicate to a user that the catheter (2400) is rotationally aligned withthe X-ray beam. As the radiopaque film is rotated, a width of thevisualized radiopaque band will increase. FIG. 24C depicts visualizedrotational indicator width as a function of rotational error of arotational indicator relative to an X-ray beam. Slight angular rotationerrors of the rotational indicator (2402) may be easily visualized dueto the sensitivity of the radiopaque film (2402).

Other rotational indicators of various configurations may allow a userto visually match an orientation of a first rotational indicator in afirst catheter to an orientation of a second rotational indicator in asecond catheter. FIGS. 25A-25B show one variation of a rotationalindicator (2500) having a cube shape with a corresponding cube-shapedcut-out (2502). The cube may have varying thicknesses, as shown in FIG.25C which depicts fluoroscopic visualization of rotational indicators asshown in FIGS. 25A-25B as a function of varying levels of rotation fromnormal (e.g., X-ray beam perpendicularity), for differing indicatorthicknesses. For two catheters having the same rotational indicator, ifthe rotational indicators appear the same in each catheter, no mattertheir misalignment from normal, then the catheters may be determined tobe rotationally aligned with respect to each other and in position forfistula formation. In another variation, FIGS. 26A-26C depict arotational indicator (2600) having a cube shape with a cylindricalcut-out (2602). FIG. 26D shows fluoroscopic images of rotationalindicators (2600) as shown in FIGS. 26A-26C as a function of rotationfrom normal, for differing hole sizes.

FIG. 27 shows distal portions of one variation of first and secondcatheters (2700, 2710) comprising rotational indicators (2708, 2718),which may be the rotational indicators of FIGS. 25A-25B or FIGS.26A-26C. Each catheter may comprise a plurality of magnets (2706, 2716),which may be cube magnets. The rotational indicators (2708, 2718) may belocated at the distal ends of the rows of cube magnets as shown, but itshould be appreciated that the rotational indicators (2708, 2718) arenot limited to a distal ends of the catheters and may be providedanywhere along the catheters. The distal ends (2702, 2712) of thecatheters may optionally additionally include a rapid exchangeatraumatic tip configured to pass a guidewire and allow tracking of thecatheter over the guidewire.

FIGS. 28A-28C illustrate fluoroscopic images of another variation of arotational indicator (2800) viewed fluoroscopically under differentangles of rotation. For instance, the rotational indicator may have ashape corresponding to an alphanumeric character such as the letter “H”or any suitable written character. FIG. 28A shows a rotational indicator(2800) as imaged by a perpendicular X-ray beam. FIGS. 28B-28C showfluoroscopic images (2802, 2804) of the same rotational indicator as inFIG. 28A under increasing angles of deviation from perpendicularity withrespect to the X-ray beam. For instance, the letter may appear thicker(2802) when slightly rotated or appear as a block (2804) after rotating90 degrees.

FIGS. 29A-29B illustrate another variation of a rotational indicator(2900) having a cross-sectional shape of the letter “R,” as shown inFIG. 29A. As the rotational indicator (2900) is rotated (FIG. 29B), theoutline of the rotational indicator may increase in thickness. FIG. 30is a cross-sectional view of a rotational indicator (3000) having anarrow shaped cut-out. FIG. 31 is a perspective view of a rotationalindicator (3100) having a “U” shaped cut-out.

The rotational indicator may comprise any radiopaque metal, such astungsten, platinum iridium, stainless steel, titanium, as well as atungsten filled polymer, zirconia ceramic, or any suitable radiopaquematerial. A visual alignment aid, such as a rotational indicator, may belocated at any suitable position on or within the catheter (e.g., one ormore surfaces of the catheter, inside of the catheter, or the like). Insome variations, one or more portions of the catheter may be made from aradiopaque material, or visual alignment aid may be attached to thecatheter by any suitable method, for example, by mechanical attachment(e.g., embedded in a portion of the catheter, circumferentialcircumscription, or the like), adhesive bonding, welding, soldering,combinations thereof or the like. In some variations in which a secondcatheter has a backstop, the backstop itself may include a rotationalindicator. For instance, a portion of the backstop may include aradiopaque material such as radiopaque zirconia ceramic. The shape ofthe radiopaque portion of the backstop may comprise any of theconfigurations described herein.

It should be appreciated that while the figures depict rotationalindicators having various illustrated cross-sections, in othervariations, the rotational indicators may have other shapes that allowfor two-dimensional visualization of rotation. For example, in othervariations the rotational indicators may be cylindrical,semi-cylindrical, or have a cross-section that is C-shaped (i.e., aD-shape or semi-cylindrical shape comprising a channel on the flatsurface), rectangular, square, triangular, trapezoidal, ovoid,elliptical, or an n^(th)-order polygon, or the like.

A procedure for aligning catheters using the rotational indicatorsdescribed is provided below. In some variations for positioning a firstcatheter and a second catheter within two vessels, a first catheter maybe advanced into a first blood vessel and a second catheter may beadvanced into a second blood vessel. The first catheter may include afirst radiopaque portion and the second catheter may include a secondradiopaque portion. An X-ray beam emitted from a fluoroscope mayfluoroscopically image an orientation of the first radiopaque portionand the second radiopaque portion, which may be shown on a display for auser.

For example, FIGS. 32A-32B are illustrative fluoroscopic images of firstand second catheters (3200, 3210). The first catheter (3200) comprises afirst coaption region (3204) comprising magnets, a first rotationalindicator (3202), and a first electrode (3206). Likewise, a secondcatheter (3210) comprises a second coaption region (3214) comprisingmagnets, a second rotational indicator (3212), and a second electrode(3216). The coaption regions (3204, 3214) and rotational indicators(3202, 3212) are of the same size and shape to allow comparison betweenthe two under fluoroscopy. Axial alignment of the catheters (3200, 3210)is shown in FIG. 32A and may be confirmed by the coaption regions (3204,3214) being in parallel with their edges lined up.

Rotational alignment of the first catheter (3200) relative to the secondcatheter (3210) may be confirmed by the rotational indicators (3202,3212) appearing substantially identical in shape and thickness. Tobetter illustrate this, FIG. 32B shows a detailed image of the firstrotational indicator (3220) axially misaligned relative to the secondindicator (3224). In particular, the rotational indicators (3220, 3224)have different thicknesses, indicating that they are rotationally offsetfrom each other. The user may rotationally adjust one or both of thecatheters (3200, 3210) until the appearance of the rotational indicators(3220, 3224) are substantially indistinguishable, thereby indicatingrotational alignment the first catheter (3200) with the second catheter(3210). It should be appreciated that the rotational indicators andcatheter alignment methods described here do not rely on an (oftenincorrect) assumption that the X-ray beam is perpendicular to a catheterplane. In other words, the catheters and rotational indicators describedhere may be aligned to each other irrespective of the incident angle ofthe X-ray beam to the catheter plane.

4. Handle

Generally, a proximal end of a catheter may comprise one or morehandles, which a user may use to manipulate the catheter as it isadvanced through vasculature. In some variations, a handle may have oneor more features to assist with axial and/or rotation alignment withanother catheter. For example, a handle may comprise a magnet and/or aflat mating surface. The handle may be coupled to a catheter shaft thatmay rotate as the handle is rotated. For example, in variationscomprising a first catheter and a second catheter each having a handle,the handles may include magnets to bring and hold the handles in closeapproximation to and alignment with each other. Alignment of the handlesmay in turn bring distal ends of the catheters into alignment.

In variations of catheter pairs comprising handles each having a magnetfor attracting and aligning the catheters in a preferred rotationaland/or axial position, the handles may each have a flat mating surfaceto orient the catheters in the correct rotational position relative toeach other. In some variations, catheter handles of first and secondcatheters may be configured to be attached to each other. They may beattached by any suitable method, such as but not limited to magnets,latches, snaps, adhesive, press fits, dovetails, etc. In this way,correct internal orientation (i.e., orientation of the catheters withinthe blood vessels) may be achieved using external visible features(i.e., the handles located external to the body).

In some variations, the ability to orient an internal portion of acatheter based on the orientation of an external portion of the catheter(e.g., a handle) may be enhanced by utilizing a catheter shaft that istorsionally stiff (e.g., a braided shaft), so that rotational alignmentat the external portion directly translates to rotational alignment of amore distal portion of the catheter. It may in some instances bedesirable for different portions of a catheter to have differenttorsional stiffnesses. For instance, a proximal portion of the shaft mayhave a first torsional stiffness and a distal portion of the shaft mayhave a second torsional stiffness greater than the first torsionalstiffness to ease rotation of the shaft along its length. In onevariation, a proximal portion of the shaft having a lower torsionalstiffness may be located distal to the handle and proximal to a magnetof a coaption region of the catheter.

As one example, FIG. 33 shows a first catheter shaft (3302) and a secondcatheter shaft (3306) coupled to a respective first handle (3300) andsecond handle (3304). The first handle (3300) and the second handle(3304) may include magnets to bring the handles together. The cathetershafts (3302, 3306) may be torsionally stiff such that rotation of thehandle will provide corresponding rotation in the catheter shaft downthrough to a distal end of the catheter. In this manner, rotationaland/or axial alignment of the handles (3300, 3304) may align thecatheters as a whole.

FIGS. 34A-34C depict a variation of a catheter (3404) comprising ahandle (3400). FIG. 34A shows the handle (3400) comprising a flatsurface for mating with a corresponding flat surface of another handle(not shown). FIGS. 34B-34C show magnets (3402) within the handle (3400)for attracting and aligning the handle in a preferred rotational and/oraxial position. The handle (3400) may thus provide aligning torque forimproved catheter alignment. It should be appreciated that the handlemay need not further comprise one or more actuation components to deployand retract a fistula-forming element through user manipulation.

H. Sensors

In one variation, systems comprising an electrode on both first andsecond catheters may further comprise an impedance metering circuit,such as a bipolar sensing circuit comprising the tissue ablationelectrodes. To measure impedance of tissue between the electrodes, lowpower DC or alternating voltage may be applied to the electrodes. Theresulting current and/or phase may be measured to determine impedance.As a user manipulates one or more catheters relative to each otherand/or as the fistula is being formed, the measured impedance values maychange to allow determination of a minimum impedance. The impedancevalues may be dependent on a number of factors, for example electrodesize, but as a non-limiting example, in one variation an initialimpedance (pre-fistula formation) may be between about 400Ω and about500Ω, and a post-fistula formation impedance may be between about 0Ω andabout 80Ω.

Additionally or alternatively, tetrapolar measurements withfiltration/signal conditioning may be utilized to determine impedance.In some variations, one or more impedance measurements may be outputtedto a user as one or more of visual and audio feedback. For example, thesystem may output an impedance value on a display meter coupled to thecatheters. Impedance values may be output as audio tones. For instance,a predetermined tone may indicate a minimum impedance valuecorresponding to catheter alignment.

I. Example Catheter System

FIGS. 36A-36G depict an exemplary variation of a single-sided electrodecatheter system (3600) comprising some of the components as describedherein. FIG. 36A illustrates a distal portion of a first catheter (3602)and a second catheter (3604). The catheters (3602, 3604) may beconfigured to be advanced through vasculature in a minimally invasivemanner. The catheters may have any suitable diameter for intravascularuse, such as, for example, about 4 French, about 5.7 French, about 6.1French, about 7 French, about 8.3 French, between about 4 French andabout 9 French, between about 4 French and about 7 French, between about4 French and about 6 French, or the like.

The first catheter (3602) may comprise a fistula-forming element (3606)and the second catheter (3604) may comprise a backstop (3608). Thebackstop (3608) may shape and control tissue ablation performed by thefistula-forming element (3606). The fistula-forming element (3606) maybe an electrode and may have the features of electrode (106) describedherein. The electrode may be attached to a housing of the first catheter(3602) and used to ablate tissue to form a fistula.

The electrode (3606) may be configured to have a low-profileconfiguration (not shown) and an extended configuration (as shown). Theelectrodes (3606) may be biased toward the extended configuration. Thatis, the electrode may be configured to self-expand from the low-profileconfiguration to the extended configuration. In some variations, theelectrode may be held in the low-profile configuration by the innersurface of a vessel wall during delivery. The electrode may thenself-expand toward the extended configuration as energy delivery throughthe electrode results in tissue ablation.

In the extended configuration, the electrode (3606) may be curved, suchthat it forms a convex curve extending away from the outer surface ofthe first catheter (3602). When the electrode (3606) moves from alow-profile to an extended configuration, the radius of curvature of theelectrode (3606) may decrease, causing the electrode (3606) to protrudefrom the first catheter (3602). Conversely, when the electrode (3606)moves from an extended configuration to a low-profile configuration, theradius of curvature of the electrode may increase, causing the electrodeto recess into an opening in the catheter body. The electrode (3606) maybe configured to slide within the first catheter (3602) when theelectrode (3606) moves between low-profile and extended configurations.More specifically, as shown in more detail with respect to FIGS. 1A-4,the electrode (3606) may comprise a first end and a second end, whereboth the first and second ends are located within the first catheter(3602). The first end of the electrode (3606) may be fixed, while asecond end of the electrode (3606) may be slidable within a lumen insideof the first catheter (3602). When the slidable second end of theelectrode (3606) moves toward the fixed first end of the electrode, theelectrode (3606) may move toward an extended configuration. When theslidable second end of the electrode (3606) moves away from the fixedfirst end of the electrode (3606), the electrode (3606) may move towarda low-profile configuration. Because the electrode (3606) is curved, asthe slidable second end moves toward the fixed first end of theelectrode (3606), the radius of curvature of the electrode (3606) maydecrease, causing the electrode (3606) to protrude from the firstcatheter (3602).

The electrode (3606) may be coupled to a power source (e.g., RFgenerator) by an electrical lead (3622) extending longitudinally througha catheter shaft (3614), that is in turn coupled to an electrical plug(3620), as shown in in the cross-sectional view of the first catheter inFIG. 36C.

As best shown in FIG. 36D, the backstop (3608) of the second catheter(3604) may have a protruding backstop. The backstop (3608) may comprisea concave shape that is configured to be complementary to the electrode(3606) of the first catheter (3602). The concave portion of the backstop(3608) may correspond to the shape of an intermediate portion of theelectrode (3606) when it is in the extended configuration. The backstop(3608) may be configured to compress tissue in a localized region forablation by the electrode (3606) of a first catheter (3602).

The first and second catheters (3602, 3604) may further compriserespective coaption regions (3610, 3624) that help align one catheterrelative to another catheter in adjacent blood vessels and/or bring thecatheters (and blood vessels) in closer approximation relative to eachother. Alignment of the first and second catheters (3602, 3604) relativeto each other may position the electrode (3606) of the first catheter(3602) at a desired axial and/or rotational orientation relative to acorresponding backstop (3608) of the second catheter (3604). Thecoaption regions (3610, 3624) may comprise one or more magnets, flatcoaption surfaces, and/or visual alignment aids (e.g., rotationalindicators).

In particular, as best shown in the perspective view of FIG. 36E, thecatheters may each have square cross-sections at least within thecaption regions (3610, 3624). As such, one side of each coaption region(3610, 3624) may form a flat coaption surface, and the two coaptionsurfaces may face each other when the catheters are properly aligned, asshown in FIG. 36E. As described herein, this may aid the rotationalalignment of the catheters; the opposing flat coaption surfaces maybring the catheters into rotational alignment with each other and closertogether with the blood vessels.

Furthermore, the catheters (3602, 3604) may comprise magnet arrayscomprising a plurality of square magnets (3626) within the coaptionregions (3610, 3624). In the first catheter (3602), the square magnets(3626) may be located proximally and distally to the electrode (3606),as shown in FIG. 36B, while in the second catheter (3604), the squaremagnets may be located proximally and distally to the backstop (3608).The magnets (3626) proximal to the electrode (3606) in the firstcatheter (3602) may comprise a lumen for the electrical lead (3622). Theelectrical lead (3622) may be covered by insulation to shield themagnets (3626) from current carried by the lead (3622). The magnets(3626) of the first catheter (3602) may be attracted to magnets of thesecond catheter (3604) to bring the catheters in closer approximationand into rotational alignment. This may coapt tissue between the flatcoaption surfaces. In some variations, the catheters (3602, 3604) maycomprise one or more rotational indicators within the coaption regions(3610, 3626), which may be visualized under fluoroscopy for a user tovisualize the catheter system (3600) in the blood vessels and manipulatethe catheters (3602, 3604) into a desired position and relativeorientation.

The catheter system (3600) may comprise a sheath (3616) configured tocover a portion of a catheter shaft (3614), as shown in FIG. 36F. Thesheath (3616) may be slidable along the length of the first catheter(3602). In some variations, in order to be slidable over portions of thecatheter having a circular cross-section and portions of the catheterhaving a square cross-section, the sheath (3616) may comprise a flexiblematerial allowing it to deform between round and square tubular shapes.In some variations, the sheath (3616) may have a length similar to thelength of the coaption region (3610). In a distal position, the sheath(3616) may cover the coaption region (3610), including the electrode(3606) and the areas of the catheter (3602) comprising magnets (3626),and may additionally cover portions of the remainder of the cathetershaft (3614). When the sheath (3616) covers the electrode (3606), theelectrode (3606) may be held in a low-profile configuration. In aproximal position, the sheath (3616) may leave the coaption region(3610), including the electrode (3606), exposed, thus allowing theelectrode (3606) to return to an extended configuration (assuming noother force constrains the electrode). Prior to delivery of the catheter(3602) into a patient's vasculature, the sheath (3616) may be in thedistal position covering the electrode (3606). As discussed herein, whenthe sheath (3616) disposed over the catheter (3602) is advanced into avessel through an access site comprising a hemostasis valve, the distalend of the sheath (3616) may, for example, be advanced into the valve,while the catheter (3606) may be advanced through the valve and sheath(3616) and into the vasculature. As the catheter (3602) is advanced, thesheath (3616) may slide proximally along the catheter shaft (3614). Inthis manner, the electrode (3606) in a low-profile configuration may becovered by the sheath (3616) to protect the electrode (3606) andcatheter (3602) from catching and/or damage as they are advanced throughthe access site.

One or both catheters (3602, 3604) may comprise a handle (3618) as shownin FIG. 36G. The handle (3618) may be located proximal to the coaptionregion (3610) and distal to the electrical plug (3620), and may becoupled to the catheter shaft (3614). The handle (3618) may be used toalign at least a proximal end of one catheter relative to at least aproximal end of another catheter. One or more portions of the cathetershaft (3614) may be torsionally stiff such that rotation of the handle(3618) is translated into rotation of the more distal portions of thecatheter. At their distal ends, the respective distal ends (3612, 3628)of the catheters (3602, 3604) may each include a rapid exchangeatraumatic tip comprising a lumen (3630) configured to pass a guidewireand allow tracking of the catheter over the guidewire.

II. Methods

Also described here are methods for forming a fistula between two bloodvessels using the catheters described herein. The two blood vessels maybe two closely-associated (e.g., adjacent) blood vessels, such as a veinand an artery, two veins, or two arteries. Generally, the methodsdescribed here comprise accessing a first blood vessel with a firstcatheter, and advancing the first catheter to a target location within afirst blood vessel. A second blood vessel may be accessed with a secondcatheter, and the second catheter may be advanced to a target locationwithin the second vessel. Once the first and/or second catheters havebeen advanced into the respective blood vessels, the catheters may beadjusted to position the catheters within the blood vessels and/orposition the blood vessels relative to each other.

In some variations, the catheters may comprise alignment features asdescribed herein that may be used to bring the two vessels toward eachother and/or to align the catheters axially and/or rotationally relativeto each other. The methods of aligning a catheter as disclosed hereinmay improve fistula formation with fewer complications. After thevessels are brought toward each other and the catheters are aligned, afistula formation site may optionally be analyzed through measurementsperformed by one or more catheter electrodes. In some variations, theblood vessels may be modified by the electrodes prior to fistulaformation to improve fistula and flow characteristics, as described inmore detail herein. In some instances, denaturing of tissue may improvepatency and blood flow of the fistula.

In some variations, one or more fistula-forming elements may beactivated to bore through, perforate, or otherwise create a passagewaybetween the two blood vessels by ablating tissue such that blood mayflow directly between the two adjoining blood vessels. When such afistula is formed, hemostasis may be created without the need for aseparate device or structure (e.g., a suture, stent, shunt, or the like)connecting or joining the blood vessels. Throughout the fistulaformation process, the condition of the blood vessels may in somevariations be monitored, for example to refine the energy applied toensure desired fistula formation. The catheters may be removed from theblood vessels and body after fistula formation. In some variations,fistula formation may be confirmed by the catheter measurements.

FIG. 35 is a flowchart generally describing a fistula-forming process(3500). It should be appreciated that any of the catheters describedherein may be used to form a fistula using the methods herein asappropriate. Generally, the process may begin where one or morecatheters are advanced to a target location in one or more blood vesselsvia an access site (3502). The first and second catheters may beadvanced in the same manner, or may be advanced in different manners.Once the first and/or second catheters have been advanced into theirrespective blood vessels, the catheters may be aligned axially androtationally with respect to each other (3504). For instance, eachcatheter may comprise one or more alignment features such as magnets,flat coaption surfaces, visual alignment aids, handles, or the like thathelp to position the catheters into a desired alignment. Additionally oralternatively, indirect visualization such as fluoroscopy may beutilized to align the catheters at a target location. In somevariations, impedance measurement may confirm alignment of the cathetersto each other.

In some variations, an analysis of the blood vessels may be optionallyperformed to determine if the site is suitable for fistula formation(3506). For instance, a nerve that is too close to a fistula site may benegatively impacted by the high temperatures experienced during afistula ablation process. In some variations, the proximity of a nerveto a fistula site may be determined using electrode measurements. Basedon the measurements of the fistula site, a determination may be made ofwhether the fistula site is suitable for fistula formation (3508). Ifthe fistula site is unsuitable, the user may reposition the catheters(3502) to a new fistula site and repeat the alignment (3504), analysis(3506), and determination (3508) steps. In some variations, tissue at afistula site or adjacent thereto may be optionally modified prior toablation (3510). For example, the electrodes may be used tonon-ablatively denature tissue to increase mechanical strength and/orshrink vessel size. For instance, a current may be applied to a locationin the vessel to denature adventitia of the blood vessel.

Tissue may be ablated to form a fistula based on patient characteristicsand fistula requirements (3512). Plasma may be generated according toenergy ablation parameters to ablate tissue. Ablation may be performedby one or more electrodes in one or more catheters. In some variations,a first and second catheter may form a fistula from opposing sides so asto provide dual ablation of a fistula. In some of these variations,synergistic ablation may be provided where an electrode of a firstcatheter ablates tissue to activate a conductive portion of a secondcatheter. In yet other variations, a first catheter may form a fistulausing an electrode against a backstop of a second catheter. Fistulaformation may optionally be confirmed, for example through impedancemeasurement (3514). The catheters may be removed from the blood vesselsand body (3516). The steps described above are described in furtherdetail below.

A. Advance Catheter

Advancement of one or more catheters through a vessel to a target siteis not particularly limited. In some variations, a first catheter may beadvanced into an artery, and a second catheter may be advanced into avein. In other variations, a first catheter may be advanced into a vein,and a second catheter may be advanced into an artery. In othervariations, a first catheter may be advanced into a first vein, and asecond catheter may be advanced into a second vein. In still othervariations, a first catheter may be advanced into a first artery and asecond catheter may be advanced into a second artery. The first and/orsecond catheters may be advanced over a guidewire or in any suitablemanner and may or may not occur under indirect visualization (e.g., viafluoroscopy, X-ray, or ultrasound). A direction of catheter advancementwith respect to blood flow is also not particularly limited—that is, acatheter may be advanced in an antegrade manner (with blood flow), or ina retrograde manner (against blood flow).

In variations where a catheter is advanced endovascularly into the ulnarartery, access to the ulnar artery may be achieved in any suitablemanner. In some variations, the methods described here compriseendovascularly advancing a distal portion of a first catheter into anulnar artery, endovascularly advancing a distal portion of a secondcatheter into a first deep ulnar vein, and forming a fistula between theulnar artery and the first deep ulnar vein. The methods may compriseendovascularly advancing a distal portion of a first catheter into aproximal ulnar artery, endovascularly advancing a distal portion of asecond catheter into a first deep ulnar vein, and forming a fistulabetween the proximal ulnar artery and the first deep ulnar vein.

In some variations, the catheter may be advanced along the brachialartery and into the ulnar artery. In some of these methods, the cathetermay be introduced into the vasculature via a brachial access site. Insome of these methods, the brachial artery may be cannulated with acannula directed distally in the brachial artery. In other variations,the catheter may be advanced along the brachial artery from an accesssite upstream of the brachial artery. For example, the catheter mayintroduced into the vasculature via a femoral artery access site, andmay be advanced to the brachial artery therefrom. In some variations,the ulnar artery may be accessed directly. In some of these variations,an ulnar access site may be formed in the ulnar artery (e.g., at adistal location in the wrist or forearm where the ulnar artery issuperficially positioned), and a catheter may be advanced in aretrograde fashion through the ulnar access site. In still othervariations, a catheter or other tool may be advanced endovascularly intothe ulnar artery through an access site in the radial artery.

In variations where a catheter or other tool is advanced endovascularlyinto a deep ulnar vein, access to the deep ulnar vein may be achieved inany suitable manner. In some variations, the catheter is introduced intothe vascular site via an access site. The venous access site may be inany suitable blood vessel, such as the basilic vein, the cephalic vein,or a brachial vein. In some variations, the catheter may be advanced toa deep ulnar vein endovascularly along the median cubital vein. Forexample in some variations, the catheter may be advanced along thebasilic vein, into the median cubital vein, and into one of the deepulnar veins via the perforating branch extending between the mediancubital vein and the deep ulnar veins. In instances where theperforating branch extends between the deep ulnar veins and the medianantebrachial vein, the catheter may be advanced from the median cubitalvein into the median vein, then into one of the deep ulnar veins.

In other variations, the catheter may be advanced to a deep ulnar veinendovascularly along the median cephalic vein. For example, in somevariations, the catheter may be advanced into the vasculature through anaccess site in the cephalic vein, and may be endovascularly advancedfrom the cephalic vein into the median cephalic vein, and into one ofthe deep ulnar veins via a perforating branch (to access the perforatingbranch, it may be necessary to advance the catheter into either themedian cubital vein or the median antebrachial vein).

In still other variations, the catheter may be advanced to a deep ulnarvein endovascularly along a brachial vein. For example, in somevariations, the catheter may be advanced into the vasculature through anaccess site in a brachial vein, and may be endovascularly advanced fromthe brachial vein into one of the deep ulnar veins in a retrogradefashion.

Methods for advancing a catheter endovascularly are described in moredetail in U.S. patent application Ser. No. 14/052,477, filed on Oct. 11,2013, and titled “DEVICES AND METHODS FOR FISTULA FORMATION,” which ishereby incorporated by reference in its entirety.

In variations where one of the catheters is configured for advancementover a guidewire, the catheter may be advanced along a guidewire. Invariations where one of the catheters has a guidewire fixedly attachedto its tip, the guidewire may be advanced through the vasculature to atarget location. In other variations, one or more external magnets mayhelp advance or position a catheter at a target site. For example, anexternal magnet may be used to help advance catheter within a bloodvessel and interact with any suitable portion of the catheter to createan attractive force between the catheter and the external magnet. Thisattractive force may be used to pull, push, or otherwise manipulate thecatheter during advancement.

In variations where a catheter comprises an electrode having low-profileand extended configurations as described in detail herein, the electrodemay be in a low-profile configuration as the catheter is advanced.Trauma due to advancement and navigation of the catheter through a bloodvessel may be reduced by recessing the electrode into the housing. Forexample, in some variations, a distal end of the electrode may beconfigured to slide freely within a catheter housing in response to anexternal force, such as force from a vessel wall, as described in moredetail herein. As the diameter of a vessel through which the catheteradvances increases, the electrode may extend away from the housing byvirtue of its spring force. Accordingly, a user need not mechanicallyrecess or extend the electrode during advancement of the cathetersthrough a vessel or during the fistula forming process.

B. Align Catheters

In some variations, each of the first or second catheters may compriseone or more alignment features, such as but not limited to magnets, flatcoaption surfaces, visual alignment aids, and/or handles, as describedin detail herein. In some variations, alignment of the first and secondcatheters to each other may comprise axial and/or rotational alignment.For example, the catheters may be oriented such that a fistula-formingelement of at least one of the first or second catheters is positionedto form a fistula in a certain location. In variations in which both thefirst and second catheters comprise fistula-forming elements, thecatheters may be oriented to align these fistula-forming elementsopposite each other. In variations in which a first catheter comprisesan electrode and a second catheter comprises a backstop, the cathetersmay be oriented to align the electrode and backstop opposite each other.

In some variations of catheters described herein, magnets within thefirst and second catheters may generate an attractive force between thecatheters, which may pull the catheters toward each other. Theattractive force may also compress tissue between the first and secondcatheters. An aligning torque may also mate the catheters together alongrespective flat coaption surfaces to achieve rotational alignment. Insome variations, the catheters may be torsionally stiff such thatrotational alignment of the handles by a user at a proximal end of thefirst and second catheters translates into rotational alignment througha distal end of the catheters.

The catheters may be visualized fluoroscopically as necessary throughoutthe fistula formation process. In variations of catheters comprisingrotational indicators, axial and rotational catheter alignment may beindirectly visualized, such as through fluoroscopy, to assist a user inaxially and/or radially aligning the catheters relative to each other.For example, under fluoroscopic imaging, rotational indicators may berotated until they appear the same under fluoroscopic visualization inorder to rotationally align the catheters relative to one another. Thisensures that the rotational indicators are aligned relative to oneanother, and not relative to the X-ray imaging beam. Once aligned, auser may bring the catheters into close approximation such that thecatheters' magnets hold the aligned catheters together.

In some variations, confirmation of alignment (e.g., axial and/orrotational) of the first and second catheters may be based on impedancemeasurements of the tissue interposed between the two electrodes. Forinstance, the catheters may be rotationally and axially aligned when theelectrodes are at a minimum distance from each other, which correspondsto a minimum tissue impedance between the catheters. Confirmation ofalignment using impedance measurement may avoid radiation exposureresulting from other methods, such as fluoroscopy.

In one variation, the system may comprise an impedance metering circuitsuch as a bipolar sensing circuit comprising the tissue ablationelectrodes. To measure impedance, low power DC or alternating voltagemay be applied to the electrodes. The resulting current and/or phase maybe measured to determine impedance. As a user manipulates one or morecatheters relative to each other, the measured impedance values maychange to allow determination of a minimum impedance. Additionally oralternatively, tetrapolar measurements with filtration/signalconditioning may be utilized to determine impedance.

In some variations, one or more impedance measurements may be outputtedto a user as one or more of visual and audio feedback. For example, thesystem may output an impedance value on a display meter coupled to thecatheters. Additionally or alternatively, impedance values may be outputas audio tones. For instance, a predetermined tone may indicate aminimum impedance value corresponding to catheter alignment.

C. Analyze Vessel

Once a potential fistula site has been identified and one or morecatheters have been advanced to the fistula site, measurement of vesselcharacteristics may optionally be used to determine the suitability ofthe site for fistula formation. In some variations, the suitability of asite for fistula formation may be based on the proximity of the site toa nerve. For instance, it may be undesirable to form a fistula close toa nerve, as the thermal energies of fistula formation may impinge on oneor more nearby nerves.

In some variations, a system may apply a low power DC or AC current in amonopolar configuration through an active electrode of a first catheterto a ground pad to induce neuromuscular stimulation. Nerve location withrespect to the fistula site may be determined based on visualization ofthe induced neuromuscular stimulation. The stimulation may be visualizedexternally (e.g., observing an arm twitch) and/or internally throughtechniques such as ultrasound and/or fluoroscopy. A high level ofinduced neuromuscular stimulation may indicate that the fistula site istoo close to a nerve and may suggest that the fistula site should berelocated by repositioning the catheters. In some variations, a set ofstimulating currents may be applied to determine the distance of thenerve from the electrode. For instance, a current of 1 microampere maybe applied and then followed by a current of 3 microamperes. Thedifference in observed neuromuscular stimulation may approximate nervevicinity.

In some variations, a baseline impedance measurement may be performedprior to fistula formation and utilized to determine ablationparameters. Baseline impedance may also be referenced when performing asecond impedance measurement to confirm fistula formation after tissueablation.

D. Modify Vessel

In some variations of the methods described herein, portions of thevessels adjacent to a fistula site may be modified to change thecharacteristics of one or more vessels and the resultant fistula. Insome variations, one or more catheters may be configured to thermallydenature and/or weld tissue structures at or adjacent to a fistula site.For example, heating tissue to 70° C. may result in denaturing. Thermaldenaturing and welding may modify the vessel without removing materialas occurs when ablating tissue. Furthermore, adhesion of tissue layersmay be beneficial towards increasing the mechanical strength betweenvessels.

In some variations, one or more catheters may be configured to deliverelectrical, ultrasonic, or laser energy to at least one of the first andsecond blood vessels to denature proteins in the vessel walls. Forexample, a catheter may comprise a fiber optic filament coupled to alaser, such that the catheter may be configured to direct laser energyto heat tissue, denature proteins, and/or weld tissue. As anotherexample, a catheter may comprise a piezoelectric element configured touse ultrasonic vibration to induce heating, denature proteins, and/orweld tissue. In some instances, tissue may be thermally welded byapplying a coagulation current through an electrode to denatureconnective tissue proteins and thereby increase adhesion between tissueplanes. A coagulation current may thermally shrink the vessel andincrease the vessel's vascular resistance. In some instances, thedenatured proteins from each blood vessel may intertwine to fusetogether. In one variation, denaturing collagen around a fistula sitewithout removing tissue is performed prior to the ablation cycle tostrengthen the fistula formed. However, a denaturing sequence may beperformed before, during, or after fistula creation.

Additionally or alternatively, impedance may be measured during athermal denaturing period by measuring the impedance in a bipolar ormonopolar circuit. As described herein, first and second catheters maycomprise an impedance metering circuit, such as a bipolar sensingcircuit. In this manner, a single heating cycle may be performed withoutinterrupting the energy delivery cycle to measure impedance. Impedancesmeasured (e.g., using a first electrode and a second electrode) beforeand after a denaturing sequence may determine the level of vesselmodification provided.

In some variations, the systems discussed herein may further comprise anelectrosurgical controller coupled to one or more electrodes forcontrolling tissue modification. In some variations, a first impedancemay be measured between a first electrode and a second electrode. Tissuemodification parameters may be selected based on the first impedance.For instance, the impedance measured may correspond to known tissuecharacteristics. These tissue characteristics may correspond topredetermined tissue modification parameters. Modification parametersmay include an energy waveform, amplitude, duration, and so forth. Thecontroller may control one more electrodes to modify tissue based on theselected modification parameters. After applying one or more pulses oftissue modification energy, a second impedance may be measured, and theprocess may be repeated until a threshold impedance is reached.

The controller may control the electrodes to measure a second impedanceand determine whether modification is complete based on the impedance.In some variations, parameters may be selected to complete modificationin a single cycle. In other variations, each cycle may be limited inpower and/or duration so as to perform a plurality of cycles to completemodification. For example, the thermal effects of denaturing may bedispersed over a longer period of time so as to limit collateral thermaldamage to a vessel.

Devices, systems, and methods for modifying vessels are described inmore detail in International Patent Application Serial No.PCT/US17/13611 filed concurrently herewith, titled “SYSTEMS AND METHODSFOR ADHERING VESSELS” and claiming the benefit of U.S. ProvisionalApplication No. 62/279,642, filed Jan. 15, 2016, which is herebyincorporated by reference in its entirety.

E. Ablate Tissue

Once the catheter or catheters are in position, one or morefistula-forming elements may be used to create a fistula between the twoblood vessels. For example, in some variations, one of the first andsecond catheters may comprise a fistula-forming element (e.g., anelectrode), while the other catheter does not comprise a fistula-formingelement. In other variations, both catheters may comprise afistula-forming element. In some of these variations, thefistula-forming elements of the first and second catheters act to formdifferent fistulas. In other variations, the fistula-forming elements ofthe first and second catheters interact to form the same fistula. Anysuitable combination of electrodes as described herein may be utilizedto form the fistula, and current may be delivered in monopolar orbipolar configurations accordingly. For example, a fistula-formingelement of the first catheter may be activated or otherwise used to forma fistula between a first blood vessel and a second adjoining bloodvessel. In still other variations, the catheters may be configured toform the fistula through the first and second blood vesselssubstantially simultaneously.

As discussed in detail herein, in variations where the fistula-formingelement of the first catheter is configured to extend or otherwise movethrough blood vessel tissue during tissue fistula formation, a secondcatheter may contact or otherwise receive the fistula-forming element ofthe first catheter as it ablates through tissue. For example, in somevariations, the second catheter may comprise one or more backstops, suchas those discussed with respect to FIGS. 13A-18B. In some of thesevariations, the backstop may be configured to receive or otherwisecontact an electrode of the first catheter as it passes through vesseltissue. In other variations, current may be passed between an electrodeof the first catheter and an electrode of the second catheter duringtissue ablation. In some of these variations, the electrode of the firstcatheter may be positioned such that it comes into contact with one ormore electrodes or conductive portions of the second catheter.

For example, in the variations illustrated in FIGS. 20A-20D, advancementof an active electrode (2008) through tissue of one blood vessel maycontact and energize the one or more conductive portions (2002) in asecond catheter in a second blood vessel. In these variations, a firstblood vessel may be a venous blood vessel and a second blood vessel maybe an arterial blood vessel, for example. Prior to contact of theelectrode (2008) with the conductive portion (2002), only the electrode(2008) is energized to ablate tissue. Upon contact of the electrode(2008) with the conductive portion (2002), the voltage of the conductiveportion (2002) rises to become an extension of the electrode (2008),such that the conductive portion (2002) may ablate tissue in contactwith the electrode (2008). When contact is broken between the electrode(2008) and the conductive portion (2002), the voltage of the conductiveportion (2002) drops and ablation by the conductive portion (2002) ends.

In variations where a fistula is formed between an artery and a vein, itmay be desirable in some instances to begin fistula formation in thevein prior to forming an opening in the artery wall. If during fistulaformulation, the first catheter malfunctions or the procedure isotherwise stopped, such that a complete fistula is not formed, formationof an opening formed in the artery without a corresponding opening beingformed in the vein is prevented. Formation of an opening in a veinwithout fully forming a fistula may result in some extravascularbleeding, but the venous pressure may be low enough such thatsignificant bleeding does not occur, which may allow the blood vessel toheal itself. In contrast, when an opening is formed in an artery withoutcompletely forming a fistula, the arterial pressure may push blood intothe extravascular space around the blood vessels, which in someinstances may require a surgical procedure to fix. Moreover, ablation ofa fistula of a larger size on a venous side of the fistula versus asmaller size on the arterial side may reduce intrafistular pressure soas to reduce the likelihood of extravasation. This is accomplished byinducing a larger pressure drop at the arterial fistula aperture.Additionally, in some variations, fistula formation using the methodsdescribed herein may form a larger opening in the first blood vesselthan the opening formed in the second blood vessel. This may be usefulin instances where the first blood vessel is a vein and the second bloodvessel is an artery. Because a larger opening may have less resistanceto blood flow than a smaller opening, forming a larger opening in thevein may promote flow from the artery to the vein, which may reduce thelikelihood of blood extravasation through a fistula into theextravascular space.

In some variations, radiofrequency energy such as radiofrequencyalternating current may be applied to one or more electrodes to generateplasma and ablate tissue as discussed in detail herein. In somevariations, the parameters may be selected based on tissue properties.For example, an impedance may be measured between a first electrode anda second electrode. Tissue ablation parameters may be selected based onthe impedance. For instance, the measured impedance may correspond toknown tissue characteristics. In conjunction with desired fistulacharacteristics, predetermined tissue ablation parameters may beselected. Tissue ablation parameters may include an energy waveform,amplitude, duration, and so forth. The controller may control the onemore electrodes to ablate tissue based on the selected ablationparameters.

In some variations, tissue ablation parameters may be selected to form afistula in a single ablation cycle. In other variations, each cycle maybe limited in power and/or duration so as to perform a plurality ofcycles to complete ablation. In these variations, the thermal effects ofablation may be dispersed over a longer period of time so as to limitcollateral thermal damage to a vessel.

Upon applying voltage to an electrode, fluid surrounding the activeelectrode may be heated to generate a vapor layer. The vapor layergenerated rapidly expands and encapsulates the electrode such that thevapor increases the impedance experienced at the electrode. Plasma isgenerated from the vapor layer when the voltage applied to the electrodeexceeds an ionization threshold. The plasma generates electrical arcswith high current density that superheats tissue and causes rapiddissociation of molecular bonds in the organic compounds.

In variations of a catheter comprising a reservoir formed behind anelectrode, a fixed volume of blood may be held in the reservoir. Thisisolation creates a fluid bolus separated from the free stream of bloodand allows a significant reduction in the time and energy needed togenerate plasma for ablation. For example, when the electrode isenergized, the fluid volume in the reservoir may rapidly vaporize andionize, thereby initiating the ablation sequence quickly. Inconfigurations comprising a fluid reservoir, the time to reachingablation plasma may be significantly reduced from about 500 msec toabout 15 msec. Reducing the time until plasma ignition may also reducethe total energy applied to tissue, thereby reducing potentialcollateral thermal damage to tissue. Without the reservoir, theelectrode may have greater difficulty in generating plasma due toconvection from the free flowing bloodstream.

The maximum voltage applied may exceed an ionization threshold of avapor layer. In some variations, an ionization threshold of a vaporlayer may be exceeded by applying a peak voltage of about 180 V. In somevariations, a constant voltage square wave may be applied via one ormore of the electrodes to reduce the overall amount of energy used togenerate and maintain plasma. For example, due to the shape and periodicnature of a sinusoidal waveform, a significant portion of a sinusoidalvoltage is below an ionization threshold. To compensate, the maximumvoltage is increased, thereby increasing energy usage and alsopotentially causing unintended damage to a vessel. However, a constantvoltage square wave may be above the ionization threshold for a higherpercentage of each cycle period in comparison to a sinusoidal waveform.Consequently, tissue ablation may be performed with less energy.

In some variations, the systems discussed herein may further comprise anelectrosurgical controller coupled to one or more electrodes forcontrolling tissue ablation. For example, in some variations, theelectrosurgical controller may control one or more electrodes in one ormore catheters. In other variations, the electrosurgical controller maycontrol a first catheter comprising one or more electrodes paired with asecond catheter comprising a backstop.

In some variations, the system may comprise a feedback circuit tomaintain the voltage at a constant level. By maintaining a constantvoltage square wave, higher current may be delivered during an ionicconduction phase when vapor is not yet formed and impedance is low. Asvapor is formed, the impedance rises and the current may be reducedaccordingly as a function of the constant voltage control of thefeedback circuit. The voltage may be maintained at a predetermined levelto provide a desired ionization intensity of the plasma. The feedbackcircuit may comprise any known control scheme such as P (proportional),PI (proportional-integral), PID (proportional-integral-derivative)control, or the like.

The size of the fistula formed may vary in size as a function of thetissue thickness. For example, if the tissue is thin, limiting theextension of the electrode out of a catheter housing by way of aprotruding backstop, for instance, may produce a smaller fistula. Forthicker tissue, the electrode may be designed to extend further out ofthe catheter housing to thereby increase the width of the formedfistula. Thus, a predetermined fistula resistance (e.g., fluid flowrate) may be maintained in the presence of variable tissue thickness.

The impedance between the electrodes may be measured before, during,and/or after an ablation cycle to measure the resistive changes in thetissue as caused by the ablation. As the tissue is removed via ablationand blood communicates through the newly-formed fistula, an impedancebetween the electrodes may drop significantly and may indicatesuccessful fistula creation. Conversely, if the impedance has notdropped to a predetermined level, a fistula may be determined to havenot completely formed. A measured impedance within a predetermined rangemay correspond to a created fistula. In one variation, a measuredimpedance of about 150 ohms or less may indicate fistula formation.

For example, a first impedance may be measured between an electrode inthe first vessel and an electrode in the second vessel. After tissueablation, a controller controls the electrodes to measure a secondimpedance and determine whether a desired fistula has been created usingthe first impedance as a reference. In one variation, an ablationparameter may comprise a tissue ablation period of 40 msec followed by a20 msec impedance measurement period without delivery of tissue ablationenergy. In another variation, an ablation parameter may comprise atissue ablation period of about 500 msec followed by an impedancemeasurement period of about 1 second. In some of these variations, themeasured impedance may be averaged over the measurement period. Thisablation cycle alternating between measurement and ablation may berepeated until a fistula is created. In some variations, the completionof fistula formation may be indicated to a user via visual and/or audiofeedback such as a confirmatory tone and/or display message. Fistulacreation and confirmation may thus confirmed without fluoroscopy.However, it should be appreciated that additionally or alternatively,fistula creation may be confirmed using imaging, such as usingfluoroscopy and injection of a contrast agent.

Additionally, in some variations, one or more balloons or expandablemembers, such as those described herein, may be used to help positionthe first and/or second catheters, or may act to hold the first and/orsecond catheters in place within the blood vessels. For example, in somevariations, expansion of a balloon or expandable member of one of thecatheters may engage the interior of a blood vessel, which may hold thatcatheter in place within the blood vessel. In other methods, theexpansion of the balloon or expandable member can bias or otherwisepress a fistula-forming element against blood vessel tissue, which mayaid fistula formation.

Additionally, one or more balloons may be activated to affect the bloodflow relative to the fistula. For example, in variations where anarterio-venous fistula is formed, it may be beneficial to dilate one ormore portions of the artery and/or veins. Specifically, the portion ofthe artery upstream of an arterio-venous fistula may be expanded toincrease flow through the fistula. Alternatively or additionally, aportion of a vein downstream from a fistula may be dilated to helpincrease flow through the fistula. In some variations, one or moreportions expandable members may comprise an electrode for inducingnecrosis or swelling in a portion of a blood vessel to decrease flowtherethrough. For example, in some variations a portion of a veinupstream from a fistula may be at least partially occluded to minimizevenous hypertension.

Although the foregoing implementations has, for the purposes of clarityand understanding, been described in some detail by of illustration andexample, it will be apparent that certain changes and modifications maybe practiced, and are intended to fall within the scope of the appendedclaims. Additionally, it should be understood that the components andcharacteristics of the devices described herein may be used in anycombination, and the methods described herein may comprise all or aportion of the elements described herein. The description of certainelements or characteristics with respect to a specific figure are notintended to be limiting or nor should they be interpreted to suggestthat the element cannot be used in combination with any of the otherdescribed elements.

We claim:
 1. A system for forming a fistula between two vesselscomprising: a first catheter comprising a housing and an electrode,wherein the electrode comprises a proximal end, an upturned distal end,and an intermediate portion between the proximal end and the upturneddistal end, wherein the electrode varies in width along a length definedfrom the proximal end to the intermediate portion, wherein the upturneddistal end is upturned relative to a longitudinal axis of the electrode,wherein the proximal end of the electrode is fixed relative to thehousing and the upturned distal end of the electrode is freelylongitudinally slidable within the housing toward a tip of the catheteraway from the proximal end; and wherein the electrode is positionedwithin a lumen of the housing, the lumen comprising a first diameterportion positioned proximal to an opening and a second diameter portionpositioned proximal to the opening, wherein the second diameter portioncomprises a smaller diameter than the first diameter portion, and theelectrode is fixed to the housing at the second diameter portion.
 2. Thesystem of claim 1, wherein the opening comprises a side opening and theintermediate portion of the electrode extends into and out of the sideopening radially beyond an outer radius of the housing.
 3. The system ofclaim 1, wherein the electrode comprises a leaf spring.
 4. The system ofclaim 1, wherein the first catheter comprises a fluid seal to preventfluid ingress into the first catheter at the proximal end of theelectrode.
 5. The system of claim 1, wherein the electrode varies inheight along its length.
 6. The system of claim 1, wherein theintermediate portion of the electrode comprises a plurality of bends. 7.The system of claim 1, wherein the intermediate portion comprises a bendof less than about 40 degrees.
 8. The system of claim 1, wherein theelectrode comprises a low-profile configuration in which the electrodeis recessed into the housing.
 9. The system of claim 1, wherein thehousing comprises a reservoir between the proximal end of the electrodeand a distal end of the first catheter, the reservoir configured to holdfluid, and wherein the electrode is configured to generate plasma fromthe fluid in the reservoir.
 10. The system of claim 1, furthercomprising a second catheter comprising a second housing and aprotruding backstop.
 11. The system of claim 10, wherein the secondcatheter comprises a recessed portion opposite the protruding backstopacross a longitudinal axis of the second catheter, wherein the recessedportion has a complementary shape to the protruding backstop.
 12. Thesystem of claim 1, further comprising a second catheter comprising arecessed backstop, wherein the recessed backstop has a shape that iscomplementary to a portion of the electrode.
 13. The system of claim 12,wherein the recessed backstop has a shape that is complementary to theintermediate portion of the electrode.
 14. The system of claim 13,wherein the electrode comprises an extended configuration in which theelectrode is extended away from the housing, and wherein thecomplementary shape corresponds to a shape of the electrode in theextended configuration.
 15. The system of claim 12, where the shapecomprises a concave portion comprising an opening configured to receivethe electrode.
 16. The system of claim 1, wherein the first cathetercomprises a first coaption region comprising a flat coaption surface.17. The system of claim 16, wherein the first coaption region has asquare or rectangular cross-section.
 18. The system of claim 16, furthercomprising a second catheter comprising a second coaption regioncomprising a flat coaption surface.
 19. The system of claim 18, whereinthe second coaption region has a square or rectangular cross-section.20. The system of claim 18, wherein the first coaption region comprisesa first magnet and the second coaption region comprises a second magnet.21. The system of claim 1, wherein the first catheter comprises a firsthandle, and the system further comprises a second catheter comprising asecond handle, wherein the first handle and the second handle eachcomprise a flat surface.
 22. The system of claim 21, wherein the firsthandle comprises a first magnet and the second handle comprises a secondmagnet.
 23. The system of claim 1, wherein the first catheter comprisesa rotational indicator comprising a radiopaque material.
 24. The systemof claim 1, wherein a width of the proximal end of the electrode isgreater than the width of the intermediate portion of the electrode. 25.The system of claim 1, wherein the width of the electrode tapers fromthe proximal end to the intermediate portion.
 26. The system of claim 1,wherein the tip of the catheter is a rapid exchange tip, and theupturned distal end of the electrode remains spaced from the rapidexchange tip.